Trial Outcomes & Findings for Feasibility and Clinically Application of Magnetic Resonance Fingerprinting (NCT NCT02387840)

NCT ID: NCT02387840

Last Updated: 2021-01-12

Results Overview

The duration of MRF sequence in minutes will be recorded as a measure of feasibility

Recruitment status

TERMINATED

Study phase

Target enrollment

35 participants

Primary outcome timeframe

Up to 1 year

Results posted on

2021-01-12

Participant Flow

Protocol enrollment was 35 but data are only available for 34 participants - Study team believes one participant's scan was never completed with MRF but because the study was terminated in 2018 with no further access to data this cannot be confirmed.

Participant milestones

Participant milestones
Measure	NF1-associated Optic Pathway Glioma (OPG) Patients with neurofibromatosis type 1 (NF1) associated OPG will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	NF1 Without Brain Tumor Patients with NF1 without brain tumor will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	Without NF1 and With Brain Tumor Exposed to Therapy Patients without NF1 and with low grade gliomas exposed to therapy will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	Without NF1 and With Untreated Low Grade Brain Tumors Patients without NF1 and with untreated low grade gliomas will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	Without NF1 and Without Brain Tumors Patients without NF1 and without brain tumor will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	Brain Tumors of Assorted Pathology Patients with brain tumors of assorted pathologies will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).
Overall Study STARTED	4	6	6	8	4	6
Overall Study COMPLETED	4	6	6	8	4	5
Overall Study NOT COMPLETED	0	0	0	0	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	NF1-associated Optic Pathway Glioma (OPG) Patients with neurofibromatosis type 1 (NF1) associated OPG will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	NF1 Without Brain Tumor Patients with NF1 without brain tumor will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	Without NF1 and With Brain Tumor Exposed to Therapy Patients without NF1 and with low grade gliomas exposed to therapy will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	Without NF1 and With Untreated Low Grade Brain Tumors Patients without NF1 and with untreated low grade gliomas will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	Without NF1 and Without Brain Tumors Patients without NF1 and without brain tumor will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	Brain Tumors of Assorted Pathology Patients with brain tumors of assorted pathologies will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).
Overall Study Death	0	0	0	0	0	1

Baseline Characteristics

Feasibility and Clinically Application of Magnetic Resonance Fingerprinting

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	NF1-associated Optic Pathway Glioma (OPG) n=4 Participants Patients with neurofibromatosis type 1 (NF1) associated OPG will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	NF1 Without Brain Tumor n=6 Participants Patients with NF1 without brain tumor will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	Without NF1 and With Brain Tumor Exposed to Therapy n=6 Participants Patients without NF1 and with low grade gliomas exposed to therapy will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	Without NF1 and With Untreated Low Grade Brain Tumors n=8 Participants Patients without NF1 and with untreated low grade gliomas will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	Without NF1 and Without Brain Tumors n=4 Participants Patients without NF1 and without brain tumor will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	Brain Tumors of Assorted Pathology n=6 Participants Patients with brain tumors of assorted pathologies will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	Total n=34 Participants Total of all reporting groups
Age, Continuous	4.5 Years n=5 Participants	17.5 Years n=7 Participants	14 Years n=5 Participants	15 Years n=4 Participants	12.5 Years n=21 Participants	14 Years n=10 Participants	15 Years n=115 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants	6 Participants n=4 Participants	3 Participants n=21 Participants	0 Participants n=10 Participants	18 Participants n=115 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	6 Participants n=10 Participants	16 Participants n=115 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	8 Participants n=4 Participants	4 Participants n=21 Participants	6 Participants n=10 Participants	34 Participants n=115 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants	8 Participants n=4 Participants	4 Participants n=21 Participants	6 Participants n=10 Participants	34 Participants n=115 Participants
Region of Enrollment United States	4 participants n=5 Participants	6 participants n=7 Participants	6 participants n=5 Participants	8 participants n=4 Participants	4 participants n=21 Participants	6 participants n=10 Participants	34 participants n=115 Participants

PRIMARY outcome

Timeframe: Up to 1 year

Population: Participants enrolled in study

The duration of MRF sequence in minutes will be recorded as a measure of feasibility

Outcome measures

Outcome measures
Measure	NF1-associated Optic Pathway Glioma (OPG) n=4 Participants Patients with neurofibromatosis type 1 (NF1) associated OPG will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	NF1 Without Brain Tumor n=6 Participants Patients with NF1 without brain tumor will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	Without NF1 and With Brain Tumor Exposed to Therapy n=6 Participants Patients without NF1 and with low grade gliomas exposed to therapy will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	Without NF1 and With Untreated Low Grade Brain Tumors n=8 Participants Patients without NF1 and with untreated low grade gliomas will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	Without NF1 and Without Brain Tumors n=4 Participants Patients without NF1 and without brain tumor will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	Brain Tumors of Assorted Pathology n=6 Participants Patients with brain tumors of assorted pathologies will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).
Average Duration of MRF Sequence - Feasibility	11 minutes Standard Deviation 0	11 minutes Standard Deviation 0	11 minutes Standard Deviation 0	11 minutes Standard Deviation 0	11 minutes Standard Deviation 0	11 minutes Standard Deviation 0

SECONDARY outcome

Timeframe: Up to 1 year

Population: Participants enrolled in study

Number of patients which have evaluable scans at both T1 and T2

Outcome measures

Outcome measures
Measure	NF1-associated Optic Pathway Glioma (OPG) n=4 Participants Patients with neurofibromatosis type 1 (NF1) associated OPG will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	NF1 Without Brain Tumor n=6 Participants Patients with NF1 without brain tumor will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	Without NF1 and With Brain Tumor Exposed to Therapy n=6 Participants Patients without NF1 and with low grade gliomas exposed to therapy will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	Without NF1 and With Untreated Low Grade Brain Tumors n=8 Participants Patients without NF1 and with untreated low grade gliomas will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	Without NF1 and Without Brain Tumors n=4 Participants Patients without NF1 and without brain tumor will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	Brain Tumors of Assorted Pathology n=6 Participants Patients with brain tumors of assorted pathologies will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).
Number of Patients With Evaluable T1 and T2 Relaxation Times on MRF Scans	4 Participants	6 Participants	6 Participants	8 Participants	4 Participants	6 Participants

SECONDARY outcome

Timeframe: Up to 1 year

Population: Participants enrolled on arms 1,3 and 4. Combination of Arms 1, 3, and 4 for reporting was pre-specified in the study protocol. Each participant had a single tumor sample measured and a single normal-appearing white matter measured.

Using Wilcoxon rank sum test to compare continuous variables, researchers will identify scans with significant difference in relaxometry between low-grade (composite of arms 1,3,4) and versus healthy brain tissue.

Outcome measures

Outcome measures
Measure	NF1-associated Optic Pathway Glioma (OPG) n=18 Participants Patients with neurofibromatosis type 1 (NF1) associated OPG will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	NF1 Without Brain Tumor n=18 Participants Patients with NF1 without brain tumor will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	Without NF1 and With Brain Tumor Exposed to Therapy Patients without NF1 and with low grade gliomas exposed to therapy will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	Without NF1 and With Untreated Low Grade Brain Tumors Patients without NF1 and with untreated low grade gliomas will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	Without NF1 and Without Brain Tumors Patients without NF1 and without brain tumor will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	Brain Tumors of Assorted Pathology Patients with brain tumors of assorted pathologies will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).
Comparison of Relaxometry MRI Scans Between Low Grade Gliomas and Healthy Brain Tissue T1	1355 milliseconds (ms) Standard Deviation 187	916 milliseconds (ms) Standard Deviation 78	—	—	—	—
Comparison of Relaxometry MRI Scans Between Low Grade Gliomas and Healthy Brain Tissue T2	56 milliseconds (ms) Standard Deviation 19	38 milliseconds (ms) Standard Deviation 8	—	—	—	—

SECONDARY outcome

Timeframe: Up to 1 year

Population: Participants in arm 6 had a measurable solid portion of HGG and were used for this analysis. Each participant had a single tumor sample measured and a single normal-appearing white matter measured.

Using Wilcoxon rank sum test to compare continuous variables, researchers will identify scans with significant difference in relaxometry between high-grade (arm 6) and versus healthy brain tissue.

Outcome measures

Outcome measures
Measure	NF1-associated Optic Pathway Glioma (OPG) n=3 Participants Patients with neurofibromatosis type 1 (NF1) associated OPG will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	NF1 Without Brain Tumor n=3 Participants Patients with NF1 without brain tumor will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	Without NF1 and With Brain Tumor Exposed to Therapy Patients without NF1 and with low grade gliomas exposed to therapy will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	Without NF1 and With Untreated Low Grade Brain Tumors Patients without NF1 and with untreated low grade gliomas will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	Without NF1 and Without Brain Tumors Patients without NF1 and without brain tumor will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	Brain Tumors of Assorted Pathology Patients with brain tumors of assorted pathologies will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).
Combination of Relaxometry MRI Scans Between High Grade Gliomas and Healthy Brain Tissue T1	1863 milliseconds (ms) Standard Deviation 70	979 milliseconds (ms) Standard Deviation 156	—	—	—	—
Combination of Relaxometry MRI Scans Between High Grade Gliomas and Healthy Brain Tissue T2	91 milliseconds (ms) Standard Deviation 13	45 milliseconds (ms) Standard Deviation 7	—	—	—	—

SECONDARY outcome

Timeframe: Up to 1 year

Population: Participants enrolled in study. Combination of Arms for reporting was pre-specified in the study protocol

Using paired t-tests or non-parametric Wilcoxon signed rank tests, researchers will identify scans with significant differences in scans of treated and untreated tumors

Outcome measures

Outcome measures
Measure	NF1-associated Optic Pathway Glioma (OPG) n=9 Participants Patients with neurofibromatosis type 1 (NF1) associated OPG will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	NF1 Without Brain Tumor n=7 Participants Patients with NF1 without brain tumor will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	Without NF1 and With Brain Tumor Exposed to Therapy Patients without NF1 and with low grade gliomas exposed to therapy will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	Without NF1 and With Untreated Low Grade Brain Tumors Patients without NF1 and with untreated low grade gliomas will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	Without NF1 and Without Brain Tumors Patients without NF1 and without brain tumor will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).	Brain Tumors of Assorted Pathology Patients with brain tumors of assorted pathologies will be imaged by magnetic resonance imaging and magnetic resonance fingerprinting Magnetic Resonance Imaging: Patients will have a scan of soft tissue using magnetic field and radio frequency pulses. Magnetic Resonance Fingerprinting: Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).
Comparison of Scans of Treated and Untreated Low Grade Gliomas (LGG) T1	1410 milliseconds (ms) Standard Deviation 180	1265 milliseconds (ms) Standard Deviation 181	—	—	—	—
Comparison of Scans of Treated and Untreated Low Grade Gliomas (LGG) T2	57 milliseconds (ms) Standard Deviation 15	47 milliseconds (ms) Standard Deviation 15	—	—	—	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 1 year

Descriptive statistics will be used to identify the T1 and T2 relaxation times for tumors of different types on pre-operative MRF scan