Actively Recruiting
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
Led by Ayal A. Aizer, MD · Updated on 2026-03-19
60
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
A
Ayal A. Aizer, MD
Lead Sponsor
V
Varian, a Siemens Healthineers Company
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new approach to brain-directed stereotactic radiation for patients with brain metastases that grow or change. The study aims to test the feasibility and effectiveness of same-day radiation planning and treatment with reduced planning margins. This phase 2 randomized trial explores whether shorter intervals between radiation planning and delivery improve targeting accuracy and potentially reduce local recurrence and radiation-related side effects. Participants will be randomly assigned to receive stereotactic radiation with either no margin (0mm) or a 1mm margin around the tumor. On the day of treatment, patients undergo a repeat brain MRI and synthetic CT scan for updated radiation planning. The treatment plan is adapted based on these same-day images before delivering the radiation. Additional imaging may be done during treatment if more than 2-3 days elapse between scans. Throughout the study, participants will be monitored with diagnostic MRIs and various assessments for up to one year. Researchers will measure how often tumors extend beyond planned margins at treatment start, local tumor control, radiation necrosis, neurocognitive function, quality of life, survival outcomes, and other neurological events. This detailed follow-up includes neurocognitive tests and symptom questionnaires to understand the impact of the treatment approach.
CONDITIONS
Brief Title
Stereotactic Radiation for Growing/Changing Brain Metastases With Same-Day Radiation Planning and Treatment With Margin Reduction
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Biopsy-proven solid malignancy with at least one intact, residual, or recurrent brain metastasis
- Brain metastasis showing growth of 1.0mm per week or more based on recent MRIs, or near brain edema, a recent surgical cavity, or another source of displacement
- Age of at least 18 years
- Karnofsky performance status of at least 60
- Estimated survival of at least 3-6 months
- Ability and willingness to provide written informed consent
You will not qualify if you...
- Inability to tolerate a brain MRI
- Inability to receive gadolinium contrast
- End stage renal disease
- Widespread, definitive leptomeningeal disease
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 to 2 visits for preliminary treatment planning and quality assurance checks
Duration - 1 day
Participants receive same-day stereotactic radiation treatment with adaptive planning based on a new MRI and synthetic CT scan performed on the treatment day.
1 visit (in-person) for same-day MRI, planning, and radiation treatment
Duration - Up to 1 year
Participants are monitored for up to 1 year after treatment to assess outcomes including local recurrence, radiation necrosis, survival, and neurocognitive function.
Regular follow-up visits over 12 months for assessments
Trial Site Locations
Total: 1 location
1
Brigham and Women's Hospital / Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
A
Ayal A Aizer, MD, MHS
I
Ivy B Ricca, BA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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