Feasibility and Clinically Application of Magnetic Resonance Fingerprinting

NCT ID: NCT02387840

Last Updated: 2021-01-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2019-07-31

Brief Summary

This study will look at the feasibility of using magnetic resonance fingerprinting (MRF) in children, adolescents and young adults (AYA) with and without brain tumors. This study will also look at subjects with and without neurofibromatosis type 1(NF1), a genetic disorder that affects the growth of nervous system cells. Further, it will explore potential ways of using of MRF signal measurements in children, adolescents, and young adults with brain tumors, including tissue characterization, looking at whether the treatment was effective, and finding metastasized tumors of unknown origin (occult tumors). To explore the feasibility and potential applications of MRF, this study will recruit up to 80 subjects but will stop once 10 subjects have usable data in each of six groups.

Detailed Description

Specific Aim 1: Demonstrate the feasibility of magnetic resonance fingerprinting (MRF) in children, adolescents and young adults (AYA) with and without brain tumors.

Specific Aim 2: Characterize the MRF signature of low-grade gliomas

Specific Aim 3: Determine whether MRF can identify occult tumor in subjects with low-grade glioma.

Specific Aim 4: Determine whether MRF can identify treatment effects in low-grade gliomas.

Specific Aim 5: Explore whether common brain tumors can be differentiated by comparing pre-operative MRF signature with pathologic diagnosis.

Outline: This study will examine the feasibility of MRF in children and AYA and determine whether quantitative measures of T1 and T2 relaxation times can be derived in subjects <35 years of age. Approximately 80 subjects will be evaluated and include subgroups where MRF may be of particular utility, including children and AYA subjects with brain tumors and subjects with neurofibromatosis type 1 (NF1). Additional aims will investigate the utility of MRF in these groups.

Conditions

Neurofibromatosis Type 1; Brain Tumor; Glioma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Magnetic Resonance Imaging

Intervention Type: DEVICE

Patients will have a scan of soft tissue using magnetic field and radio frequency pulses.

Magnetic Resonance Fingerprinting

Intervention Type: DEVICE

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

Group Type: EXPERIMENTAL

Magnetic Resonance Imaging

Intervention Type: DEVICE

Patients will have a scan of soft tissue using magnetic field and radio frequency pulses.

Magnetic Resonance Fingerprinting

Intervention Type: DEVICE

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

Group Type: EXPERIMENTAL

Magnetic Resonance Imaging

Intervention Type: DEVICE

Patients will have a scan of soft tissue using magnetic field and radio frequency pulses.

Magnetic Resonance Fingerprinting

Intervention Type: DEVICE

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

Group Type: EXPERIMENTAL

Magnetic Resonance Imaging

Intervention Type: DEVICE

Patients will have a scan of soft tissue using magnetic field and radio frequency pulses.

Magnetic Resonance Fingerprinting

Intervention Type: DEVICE

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

Group Type: EXPERIMENTAL

Magnetic Resonance Imaging

Intervention Type: DEVICE

Patients will have a scan of soft tissue using magnetic field and radio frequency pulses.

Magnetic Resonance Fingerprinting

Intervention Type: DEVICE

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

Group Type: EXPERIMENTAL

Magnetic Resonance Imaging

Intervention Type: DEVICE

Patients will have a scan of soft tissue using magnetic field and radio frequency pulses.

Magnetic Resonance Fingerprinting

Intervention Type: DEVICE

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).

Interventions

Magnetic Resonance Imaging

Patients will have a scan of soft tissue using magnetic field and radio frequency pulses.

Intervention Type: DEVICE

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).

Intervention Type: DEVICE

Other Intervention Names

MRI; MRF

Eligibility Criteria

Inclusion Criteria

• Subjects undergoing MRI evaluation of the brain
• NF1 status will be determined by clinical exam or genetic testing
• NF1-associated Optic Pathway Glioma (OPG) will be defined as radiographic evidence of glioma along the optic nerve, chiasm, tract or radiation in a child with NF1
• Untreated low grade gliomas will be imaging-defined gliomas that have not yet been exposed to radiation or systemic chemotherapy. Those exposed to therapy will have had radiation and/or systemic chemotherapy more than 1 month prior to scans

Exclusion Criteria

• History of mental retardation unrelated to brain tumor
• Presence of a genetic disorder other than NF1 that effects cognition or is associated with MR imaging abnormalities (e.g. tuberous sclerosis)
• History of cerebrovascular accident (stroke)
• Birth weight below five pounds, premature birth prior to 36 weeks of gestation, or ischemic episode at birth
• Major psychiatric diagnosis prior to neuro-oncological diagnosis

• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Deborah R Gold, MD

Role: PRINCIPAL_INVESTIGATOR

Case Comprehensive Cancer Center

Locations

Rainbow Babies and Children's Hospital

Cleveland, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

NCI-2015-00301

Identifier Type: REGISTRY

Identifier Source: secondary_id

CASE7314

Identifier Type: -

Identifier Source: org_study_id