Trial Outcomes & Findings for An Investigational Scan (7T MRI) for the Imaging of Central Nervous System Tumors (NCT NCT04539574)

Last Updated: 2025-01-08

Results Overview

Contrast-to-noise ratio (CNR) refers to the difference in signal intensity between the tumor and surrounding tissue. Higher CNR values indicate better image quality.

Recruitment status

COMPLETED

Study phase

Target enrollment

50 participants

Primary outcome timeframe

1 year

Results posted on

2025-01-08

Participant Flow

Patients 13 years old and above with newly identified and untreated primary brain tumor or metastasis of at least 5 mm or greater in size. Up to twenty (20) healthy volunteers will be studied for the purposes of MRI sequence optimization

Participant milestones

Participant milestones
Measure	Group 1 Healthy Volunteers	Group 2 Patients (13 years old and above)
Overall Study STARTED	8	30
Overall Study COMPLETED	8	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An Investigational Scan (7T MRI) for the Imaging of Central Nervous System Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 n=8 Participants Healthy Volunteers	Group 2 n=30 Participants Patients (13 years old and above)	Total n=38 Participants Total of all reporting groups
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	8 participants n=5 Participants	30 participants n=7 Participants	38 participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants	24 Participants n=7 Participants	32 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	6 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	18 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	12 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 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
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	27 Participants n=7 Participants	32 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Contrast-to-noise ratio (CNR) refers to the difference in signal intensity between the tumor and surrounding tissue. Higher CNR values indicate better image quality.

Outcome measures

Outcome measures
Measure	Group 1 n=8 Participants Healthy Volunteers	Group 2 n=30 Participants Patients (13 years old and above)
Contrast-to-noise Ratio (CNR)	60.6 contrast-to-noise ratio Standard Deviation 26.6	58.4 contrast-to-noise ratio Standard Deviation 28.0

Adverse Events

Group 1

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Max Wintermark, MD

M.D. Anderson Cancer Center

Phone: 713-792-0845

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place