NCT06101069 · Case Comprehensive Cancer Center
Development of MRF for Characterization of Brain Tumors After Radiotherapy
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
- 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 unable to lay still in the scanner for 30 minutes at a time.
Where
- Cleveland, Ohio
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 5, 2026 · Source of record for eligibility and locations