Status:
RECRUITING
Development of MRF for Characterization of Brain Tumors After Radiotherapy
Lead Sponsor:
Case Comprehensive Cancer Center
Collaborating Sponsors:
The Cleveland Clinic
Conditions:
Brain Tumor
Brain Necrosis
Eligibility:
All Genders
21-60 years
Phase:
NA
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-qua...
Detailed Description
Although Stereotactic radiosurgery (SRS) is utilized as an effective treatment method, after several months to over 1 year following SRS, 33% of treated brain metastases increase in size on imaging, w...
Eligibility Criteria
Inclusion
- Inclusion Criteria for Healthy Participants:
- 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: 21 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.
- 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.
Exclusion
Key Trial Info
Start Date :
October 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06101069
Start Date
October 14 2024
End Date
June 1 2026
Last Update
June 6 2025
Active Locations (2)
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1
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106
2
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195