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MRF for Brain Tumor Characterization After Radiotherapy

This study is exploring a new Magnetic Resonance Imaging (MRI) technique called Magnetic Resonance Fingerprinting (MRF) combined with IVIM MRI. The goal is to see if this method can quickly and easily create high-quality brain images to tell the difference between a brain tumor that has come back and radiation necrosis (damage to brain tissue from radiation treatment). You could be eligible if you are between 18 and 60 years old and have a brain tumor (either recurrent or previously untreated), radiation necrosis, or are a healthy individual without brain disease. The researchers will compare different measurements from the MRI scans to see how well this new technique works. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 90 participants. It is not specified if it is randomized or blinded.
What's involved
Participants will undergo an MRF and IVIM MRI scan without contrast, which will take between 30-45 minutes.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoints (T1 and T2 relaxation times, proton density maps) are measured within the total 30-45 minute scan time, so no long-term follow-up is specified.

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NCT06101069

Development of MRF for Characterization of Brain Tumors After Radiotherapy

Recruiting
NAAges 18–60InterventionalDiagnostic
Case Comprehensive Cancer Center
~90 participants
Updated 2026-05-05 on ClinicalTrials.gov
What's tested:MRF in conjunction with IVIM MRI without contrast

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Comparison of T1 relaxation times
Measured over Within the total 30-45 minute scan time
+5 more outcomes measured

Conditions

Brain Tumor
Brain Necrosis
Brain Metastases
Glioma

Explore related trials

Brain necrosisBrain NeoplasmGliomaMetastatic Malignant Neoplasm in the BrainRadiation Necrosis

Where it's being run

2 sites across 1 states
Ohio2

Study leadership

  • Lan Lu, PhD · PRINCIPAL_INVESTIGATOR · Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
  • Samuel Chao, MD · PRINCIPAL_INVESTIGATOR · Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center

Who to contact

Lan Lu, PhD
[email protected]
1-866-223 8100
Email the study team

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Eligibility criteria

Inclusion

Ages 18 - 60
No history of cerebrovascular disease
No cognitive impairments
Able to provide informed consent
Biopsy-proven cases of developed recurrent tumor or radiation necrosis, OR
a. PET identified with developed recurrent tumor or radiation necrosis. OR
b. Highly suspicious case with developed recurrent tumor or radiation necrosis confirmed by tumor board, attending physician or surgeon.
ECOG performance status 0-2.
Life expectancy \> 6 months.
Participant with other sites of extracranial metastatic disease or any prior or current systemic therapies will be considered and evaluated by the investigators of the study on a subject basis.
Radiology identified with developed primary gliomas tumor or brain metastases, OR
a. PET identified with developed gliomas tumor or brain metastases, OR
b. Highly suspicious case with developed gliomas tumor or brain metastases confirmed by tumor board
Participants must not have received prior radiation or surgical treatment for brain metastases or primary glioma.
Age: 18 years and over
ECOG performance status 0-2
Life expectancy \> 6 months.
Participant with other sites of extracranial metastatic disease or any prior or current systemic therapies will be considered and evaluated by the investigators of the study on a subject basis.
Radiology identified with resectable meningioma
Participants have no prior radiation or surgical treatment for brain lesions
Age: 18 years or older
ECOG performance status 0-2
Life expectancy \> 6 months.
Participants with other sites of extracranial metastatic disease or any prior or current systemic therapies will be considered and evaluated by the investigators of the study on a subject basis.

Exclusion

Pregnant women OR lactating women
Participants with ferromagnetic or otherwise non-MRI compatible aneurysm clips.
Participants who cannot go into the MRI scanner due to metal implants and other medical conditions.
The presence of an implanted medical device that is not MRI-compatible, including, but not limited to: pacemaker, defibrillator.
Participants with contraindications for MRI due to embedded foreign metallic objects such as bullets, shrapnel, metalwork fragments, or other metallic material.
Known history of severe claustrophobia.
Participants unable to lay still in the scanner for 30 minutes at a time.

What this trial measures

  • Comparison of T1 relaxation timesWithin the total 30-45 minute scan time

    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.

  • Comparison of T2 relaxation timesWithin the total 30-45 minute scan time

    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.

  • Comparison of proton density mapsWithin the total 30-45 minute scan time

    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.

  • Comparison of water diffusion in brain tissuesWithin the total 30-45 minute scan time

    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.

  • Comparison of blood perfusion in brain tissuesWithin the total 30-45 minute scan time

    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.

  • Comparison of MRF imaging tool in different participant populationsWithin the total 30-45 minute scan time

    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).