Development of MRF for Characterization of Brain Tumors After Radiotherapy (NCT06101069) | Clinical Trial Compass
RecruitingNot Applicable
Development of MRF for Characterization of Brain Tumors After Radiotherapy
United States90 participantsStarted 2024-10-14
Plain-language 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-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
Age range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Comparison of T1 relaxation times
Timeframe: Within the total 30-45 minute scan time
2
Comparison of T2 relaxation times
Timeframe: Within the total 30-45 minute scan time
3
Comparison of proton density maps
Timeframe: Within the total 30-45 minute scan time
4
Comparison of water diffusion in brain tissues
Timeframe: Within the total 30-45 minute scan time
5
Comparison of blood perfusion in brain tissues
Timeframe: Within the total 30-45 minute scan time
6
Comparison of MRF imaging tool in different participant populations
Timeframe: Within the total 30-45 minute scan time