Clinical trial Recruiting at 2 sites Interventional Ages 18 to 60

Using MRI to Differentiate Between Brain Tumors and Radiation Effects

Official title: Development of Magnetic Resonance Fingerprinting for Characterization of Brain Tumors After Radiotherapy

Run by Case Comprehensive Cancer Center · NCT06101069 · Data updated 2026-11-12

This study is testing a new MRI technique to see if it can help tell the difference between brain tumors and radiation damage in people who have had radiation therapy.

Quick facts

Study typeInterventional
Ages18 Years to 60 Years
SexAll
Enrollment90 (estimated)
SponsorCase Comprehensive Cancer Center
Academic / other
Drugs / interventionsradiation
Locations2 sites (Cleveland, Ohio and 1 other locations)
StatusRecruiting
StartedOctober 14, 2024
Main results expectedJanuary 2027
Study endsSeptember 2027
Registry record updatedOctober 20, 2026
Trial IDNCT06101069 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include individuals with a history of brain tumors or radiation therapy, as well as healthy individuals without brain diseases.

Probably not a fit

Patients with acute neurological conditions or those who are unable to undergo MRI due to contraindications may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study explores the use of Magnetic Resonance Fingerprinting (MRF) combined with intravoxel incoherent motion (IVIM) MRI to create high-quality images of the brain in just 5 minutes. The goal is to differentiate between brain tumors and radiation necrosis in patients who have undergone radiation therapy. Participants will include individuals with a history of brain tumors or radiation treatment, as well as healthy controls. The study aims to provide a non-invasive imaging solution that could replace the need for invasive biopsies.

Why it matters

Potential benefit: If successful, this approach could significantly improve the accuracy of brain tumor diagnosis and treatment planning, reducing the need for invasive procedures.

How similar studies have gone: Other studies utilizing advanced MRI techniques have shown promise in improving diagnostic accuracy, suggesting potential success for this novel approach.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria for Healthy Participants:

* Ages 18 - 60
* No history of cerebrovascular disease
* No cognitive impairments
* Able to provide informed consent

Inclusion Criteria for Participants with Brain Tumors:

* 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.
* 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.

Inclusion Criteria for Participants with Brain Metastases or Primary Gliomas:

* 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.

Inclusion Criteria for Participants with Meningiomas:

* 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 Criteria:

* 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 under the age of 18
* Participants unable to lay still in the scanner for 30 minutes at a time.

Where it's running

  • University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
    Cleveland, Ohio, United States
    Recruiting
  • Cleveland Clinic Taussig Cancer Center
    Cleveland, Ohio, United States
    Recruiting

Study contacts

  • Principal investigator: Lan Lu, PhD — Cleveland Clinic Taussig Cancer institute, Case Comprehensive Cancer Center
  • Study coordinator: Lan Lu, PhD
  • Email: TaussigResearch@ccf.org
  • Phone: 1-866-223 8100

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.