NCT07132190 Stereotactic Radiation for Growing/Changing Brain Metastases With Same-Day Radiation Planning and Treatment With Margin Reduction
| NCT ID | NCT07132190 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Ayal A. Aizer, MD |
| Condition | Brain Metastases, Adult |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-12-30 |
| Primary Completion | 2028-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 60 participants in total. It began in 2025-12-30 with a primary completion date of 2028-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this study is to evaluate the feasibility and effectiveness of same-day radiation planning and treatment. The study will shorten the time interval between radiation planning (radiation mapping) and radiation treatment. The intent of this shorter time interval is to increase the likelihood that the brain metastases being treated remain fully within the high-dose radiation fields. Participants will be randomized to receive brain-directed stereotactic radiation with a 1mm margin or 0mm margin, have their simulation/radiation planning imaging on the same day that brain-directed stereotactic radiation is delivered, and have repeat simulation/radiation planning scans during the course of treatment if more than 2-3 days have elapsed since the most recent scans.
Eligibility 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
Contact & Investigator
Ayal A Aizer, MD, MHS
PRINCIPAL INVESTIGATOR
Dana-Farber/Brigham and Women's Cancer Center
Frequently Asked Questions
Who can join the NCT07132190 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Brain Metastases, Adult. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07132190 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07132190 currently recruiting?
Yes, NCT07132190 is actively recruiting participants. Contact the research team at aaaizer@partners.org for enrollment information.
Where is the NCT07132190 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT07132190 clinical trial?
NCT07132190 is sponsored by Ayal A. Aizer, MD. The principal investigator is Ayal A Aizer, MD, MHS at Dana-Farber/Brigham and Women's Cancer Center. The trial plans to enroll 60 participants.