Using MRI to Differentiate Between Brain Tumors and Radiation Effects
Development of Magnetic Resonance Fingerprinting for Characterization of Brain Tumors After Radiotherapy
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Case Comprehensive Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Cleveland, Ohio and 1 other locations) |
| Trial ID | NCT06101069 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals with a history of brain tumors or radiation therapy, as well as healthy individuals without brain diseases.
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.
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 performed: Other studies utilizing advanced MRI techniques have shown promise in improving diagnostic accuracy, suggesting potential success for this novel approach.
Eligibility criteria
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. * 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 this trial is running
Cleveland, Ohio and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.