Same-day stereotactic radiation with reduced planning margins for growing or changing brain metastases
A Double-Blind Phase II Randomized Study of Adaptively Delivered LINAC-Based Stereotactic Radiation for Volatile Brain Metastases With Same-Day Planning and Margin Reduction
This trial will try to see if doing MRI planning and stereotactic radiation on the same day, with either a 0 mm or 1 mm treatment margin, helps adults with growing or unstable brain metastases stay on target and reduce side effects.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Brigham and Women's Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT07132190 on ClinicalTrials.gov |
What this trial studies
This randomized phase 2 study enrolls adults with biopsy-proven solid tumor brain metastases that are growing or causing local displacement and randomizes them to stereotactic radiation using either a 0 mm or 1 mm planning target volume margin. A preliminary plan is generated from a diagnostic MRI, then on the day of treatment a repeat MRI is taken, a synthetic CT is created, and the plan is adapted to the new imaging before delivering stereotactic radiosurgery or radiotherapy. Repeat simulation scans are obtained during the course of treatment if more than 2–3 days have passed since the most recent scans. The trial aims to determine feasibility, the effect of shortened planning-to-treatment time and tighter margins on local control, and rates of radiation necrosis.
Who should consider this trial
Good fit: Adults (≥18) with biopsy-proven solid tumor brain metastases that are growing or are near edema, a recent surgical cavity, or another source of displacement, with Karnofsky performance status ≥60 and an estimated survival of at least 3–6 months who can undergo MRI and consent to same-day planning/treatment.
Not a fit: Patients with widely disseminated intracranial disease (e.g., diffuse leptomeningeal disease), very poor performance status or very limited life expectancy, inability to undergo MRI, or lesions that are stable and not at risk for interval displacement are unlikely to benefit.
Why it matters
Potential benefit: If successful, this approach could improve local tumor control and lower the risk of radiation necrosis by reducing margins and ensuring the target is accurately imaged immediately before treatment.
How similar studies have performed: Institutional and single-arm reports of adaptive stereotactic radiosurgery suggest feasibility and potential reductions in toxicity with tighter margins, but randomized data and same-day MRI-to-treatment workflows remain limited and relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Participants must have a biopsy proven solid malignancy with at least one intact, residual or recurrent, intracranial lesion radiographically consistent with or pathologically proven to be a brain metastasis meeting one of the following criteria: 1. Growth of 1.0mm per week or more, on average, based on the two most recent brain MRIs preceding study enrollment 2. Abutment, to within 1.0cm, of a region of intracranial edema 3. Proximity (within 5.0cm) to a surgical cavity created within 30 days of enrollment 4. Proximity (within 5.0cm) to another source of physical displacement 2. Age of at least 18 years 3. Karnofsky performance status of at least 60 4. Estimated survival of at least 3-6 months in the opinion of the enrolling clinician and/or study PI 5. Ability to understand and the willingness to sign a written informed consent document by either ink on paper or a DF/HCC approved eConsent medium Exclusion Criteria: 1. Participants who cannot tolerate a brain MRI 2. Patients who cannot receive gadolinium 3. Participants with end stage renal disease 4. Participants with widespread, definitive leptomeningeal disease 5. Pregnant women are excluded from this study because of the potential deleterious effects of gadolinium on the developing fetus. Because there is an unknown but potential risk for adverse events in nursing infants, women who are breastfeeding are not eligible for this study as well
Where this trial is running
Boston, Massachusetts
- Brigham and Women's Hospital / Dana-Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Ayal A Aizer, MD, MHS — Dana-Farber/Brigham and Women's Cancer Center
- Study coordinator: Ayal A 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.