Using MRI to distinguish between tumor recurrence and radiation effects in brain metastases

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.