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Phase 2 Study of MRI for Brain Metastasis After Radiation

This research study is looking at a special way to use Magnetic Resonance Imaging (MRI) of the brain. The goal is to tell the difference between a brain tumor that has grown back and changes caused by radiation treatment, after a brain metastasis (cancer that has spread to the brain) has been treated with focused radiation. This study is for adults aged 18 and older who have a solid cancer that started outside the brain and has spread to the brain, and who have already received focused radiation for it. The researchers want to see how well this special MRI technique, called Treatment Response Assessment Maps (TRAMs), can accurately identify tumor recurrence. The study is currently unclear on its recruitment status and plans to enroll 101 participants.

Study design
This is a Phase II interventional study. It is designed to enroll 101 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, sensitivity, is measured within 3 months of study enrollment.

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NCT04033497

Treatment Response Assessment Maps to Delineate Necrosis From Tumor After Stereotactic Radiation in Brain Metastases

Recruiting
NAAges 18+InterventionalDiagnostic
Brigham and Women's Hospital
~101 participants
Updated 2026-03-19 on ClinicalTrials.gov
What's tested:MRI

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sensitivity
Measured over Within 3 months of study enrollment

Conditions

Brain Tumor

Explore related trials

Metastatic Malignant Neoplasm in the Brain

Where it's being run

2 sites across 1 states
Massachusetts2

Study leadership

  • Ayal Aizer, MD · PRINCIPAL_INVESTIGATOR · Brigham and Women's Hospital

Who to contact

Ayal Aizer, MD, MHS
[email protected]
617-732-7560
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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • SensitivityWithin 3 months of study enrollment

    The sensitivity along with 95% exact binomial confidence interval of pre-operative treatment response assessment maps for the identification of viable tumor relative to the gold standard of pathologic review