Using MRI to distinguish between tumor recurrence and radiation effects in brain metastases
Treatment Response Assessment Maps (TRAMs) in the Delineation of Radiation Necrosis From Tumor Progression After Stereotactic Radiation in Patients With Brain Metastases: A Prospective Study
This study is testing if new MRI techniques can help tell the difference between a returning brain tumor and changes caused by radiation in patients with brain metastases.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 101 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT04033497 on ClinicalTrials.gov |
What this trial studies
This research investigates the use of advanced MRI techniques, specifically Treatment Response Assessment Maps (TRAMs), to differentiate between tumor recurrence and radiation-induced changes in patients with brain metastases. The study aims to improve diagnostic accuracy and potentially allow patients to avoid unnecessary surgical interventions. Participants will undergo MRI scans to assess their brain lesions after receiving stereotactic radiation treatment. The goal is to enhance the understanding of imaging biomarkers in the context of brain tumors.
Who should consider this trial
Good fit: Ideal candidates include adults with a confirmed solid malignancy and evidence of brain metastasis who have experienced lesion enlargement after prior stereotactic radiation.
Not a fit: Patients without a history of brain metastases or those who have not undergone stereotactic radiation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could help patients avoid unnecessary surgeries by accurately identifying whether a lesion is a tumor recurrence or a benign radiation effect.
How similar studies have performed: While the use of advanced imaging techniques is gaining traction, this specific approach utilizing TRAMs for this purpose is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants must have a histologically or cytologically confirmed solid malignancy of extracranial origin and radiographic evidence of at least one brain metastasis for which stereotactic radiation was utilized in the past. Patients with intracranial pathologic confirmation of a malignancy which originated extracranially but for which extracranial disease has not been biopsied are eligible. * Participants must have an enlarging lesion in the brain at least 4 months after prior stereotactic radiation to the same site for which neurosurgical resection is planned as routine standard of care. * Participants must be age 18 years or older. * Participants must be willing to undergo study procedures. * The effects of gadolinium / other MRI-based contrast agents on the developing human fetus are unknown. For this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately. * Participants must possess the ability to understand and the willingness to sign a written informed consent document via ink on paper or via an electronic signature medium such as Adobe Sign. Exclusion Criteria: * Participants who have a contraindication to MRI (e.g. non compatible implanted metallic device for which MRI is absolutely contraindicated). * Participants who have chronic kidney disease stage IV-V or end stage renal disease. * Participants with a history of anaphylactic reactions to gadolinium. * Pregnant women are excluded from this study because gadolinium-based agents have not been proven to be safe to administer to a developing fetus. Similarly, breastfeeding women will be excluded from this study.
Where this trial is running
Boston, Massachusetts and 1 other locations
- Brigham and Women's Hospital — Boston, Massachusetts, United States (Recruiting)
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Ayal Aizer, MD — Brigham and Women's Hospital
- Study coordinator: Ayal Aizer, MD, MHS
- Email: aaaizer@partners.org
- Phone: 617-732-7560
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.