Brief Summary

The purpose of this study is to discover the potential convenience and ease of using a Magnetic Resonance Imaging (MRI) technique, named Magnetic Resonance Fingerprinting (or MRF), to achieve high-quality images within a short scan time of 5 min for viewing the entire brain. This is an advanced quantitative assessment of brain tissues. This method is being applied with IVIM MRI to be able to tell the difference between a brain with radiation necrosis and a brain with tumor recurrence. Participants will consist of individuals who have received radiation therapy in the past and were diagnosed with radiation necrosis, individuals with recurrent tumors, individuals with previously untreated tumors, and healthy individuals who have no brain diseases and have not had radiation treatment to the brain. Participants will undergo an MRI scan at a one-time research study visit; no extra tests or procedures will be required for this research study. The primary objectives of this study are:

To demonstrate the clinical feasibility of combining MRF with state-of-the-art parallel imaging techniques to achieve high-resolution quantitative imaging within a reasonable scan time of 5 min for whole brain coverage.
To apply the developed quantitative approach in combination with IVIM MRI for differentiation of tumor recurrence and radiation necrosis.
To investigate the effect of radiation dose on the development of radiation necrosis and tumor recurrence.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for not_applicable

Timeline

4mo left

Started Oct 2024

Typical duration for not_applicable

Geographic Reach

1 country

2 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.9 years study duration

Study Progress83%

Oct 2024Sep 2026

First Submitted

Initial submission to the registry

October 20, 2023

Completed

5 days until next milestone

First Posted

Study publicly available on registry

October 25, 2023

Completed

12 months until next milestone

Study Start

First participant enrolled

October 14, 2024

Completed

1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

May 5, 2026

Status Verified

April 1, 2026

Enrollment Period

1.9 years

First QC Date

October 20, 2023

Last Update Submit

April 29, 2026

Conditions

Brain Tumor Brain Necrosis Brain Metastases Glioma

Keywords

Magnetic Resonance FingerprintingRadiation necrosis

Outcome Measures

Primary Outcomes (6)

Comparison of T1 relaxation times
The primary objective is to use MRF and IVIM MRI to demonstrate clinical feasibility and differentiation of tumor recurrence and radiation necrosis. This will be measured by the 3D-MRF T1 relaxation times. The difference in mean T1 between each cohort of participants will be measured.
Within the total 30-45 minute scan time
Comparison of T2 relaxation times
The primary objective is to use MRF and IVIM MRI to demonstrate clinical feasibility and differentiation of tumor recurrence and radiation necrosis. This will be measured by the 3D-MRF T2 relaxation times. The difference in mean T2 between each cohort of participants will be measured.
Within the total 30-45 minute scan time
Comparison of proton density maps
The primary objective is to use MRF and IVIM MRI to demonstrate clinical feasibility and differentiation of tumor recurrence and radiation necrosis. This will be measured by comparing the MRF proton density maps of each cohort of participants. This will be compared using a t-test.
Within the total 30-45 minute scan time
Comparison of water diffusion in brain tissues
The primary objective is to use MRF and IVIM MRI to demonstrate clinical feasibility and differentiation of tumor recurrence and radiation necrosis. This will be measured by comparing the diffusion parameters measured by the IVIM method between the three cohorts of participants. This will be compared using a t-test.
Within the total 30-45 minute scan time
Comparison of blood perfusion in brain tissues
The primary objective is to use MRF and IVIM MRI to demonstrate clinical feasibility and differentiation of tumor recurrence and radiation necrosis. This will be measured by comparing the perfusion parameters measured by the IVIM method between the three cohorts of participants. This will be compared using a t-test.
Within the total 30-45 minute scan time
Comparison of MRF imaging tool in different participant populations
The objective is to compare the effects of radiation dose on development of radiation and necrosis and tumor recurrence by comparing participants in all cohorts (healthy participants with no brain disease, participants with brain tumors (treated), participants with brain metastases or primary gliomas (previously untreated)). The predictive ability will be assessed by comparing univariable ROC analysis, quantified using area under the curve (AUC).
Within the total 30-45 minute scan time

Study Arms (6)

Healthy Volunteer Participants

EXPERIMENTAL

Healthy volunteers will be recruited to evaluate the capability of MRF in conjunction with intravoxel incoherent motion (IVIM) MRI and serve as healthy control data to compare with the participant data.