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Stereotactic Radiation for Growing/Changing Brain Metastases With Same-Day Radiation Planning and Treatment With Margin Reduction

  • PhasePhase 2
  • StatusRecruiting
  • Planned enrollment60 people
  • Recruiting US sites1
  • SponsorAyal A. Aizer, MD
  • RegistryNCT07132190

Recruitment re-checked on ClinicalTrials.gov Oct 30, 2026. Public record; not medical advice.

Stereotactic Radiation for Growing/Changing Brain Metastases With Same-Day Radiation Planning and Treatment With Margin Reduction: a one-minute explainerNCT071321901 min

Eligibility

Who can join

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

  • Age18 Years to no maximum
  • SexAll
  • Healthy volunteersNo

You may be able to join if

  • 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:
  • Growth of 1.0mm per week or more, on average, based on the two most recent brain MRIs preceding study enrollment
  • Abutment, to within 1.0cm, of a region of intracranial edema
  • Proximity (within 5.0cm) to a surgical cavity created within 30 days of enrollment
  • Proximity (within 5.0cm) to another source of physical displacement
  • Age of at least 18 years
  • Karnofsky performance status of at least 60
  • Estimated survival of at least 3-6 months in the opinion of the enrolling clinician and/or study PI
  • 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

You cannot join if

  • Participants who cannot tolerate a brain MRI
  • Patients who cannot receive gadolinium
  • Participants with end stage renal disease
  • Participants with widespread, definitive leptomeningeal disease
  • 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

The treatment

How it is intended to work

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

Treatments listed in the registry

  • Linear accelerator-based stereotactic radiation for brain metastases using 0mm or 1mm PTV (Radiation): Linear accelerator-based stereotactic radiation for brain metastases using 0mm or 1mm PTV

The study

Treatment groups

Randomized · Parallel · masking: Quadruple

0mm PTV (Experimental)

0mm uncertainty margin

1mm PTV (Active Comparator)

1mm uncertainty margin

What it involves

Procedures

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

  • CT scans: Part of the study plan
  • MRI: Part of the study plan

Goals

What the study measures

Main goals

  • To assess the percentage of patients that demonstrate tumor beyond the standard planning margin (1.0mm PTV) at the time of stereotactic treatment. (Diagnostic MRI to MRI on first day of treatment)

Other goals

  • Overall survival
  • Death due to neurologic disease progression
  • Performance status
  • Progression free survival
  • Quality of life/symptom burden and interference
  • Neurocognitive function via Hopkins Verbal Learning Test-Revised
  • Time to detection of new brain metastases
  • Time to development of radiation necrosis
  • Time to development of leptomeningeal disease
  • Time to local recurrence
  • Time to salvage craniotomy
  • Time to additional radiotherapeutic treatments after the initial course
  • Time to the development of seizures
  • Neurocognitive function via Trail Making Test Part A and B (TMT)
  • Neurocognitive function via Controlled Word Association Test (COWAT)
  • Neurocogntive function via Mini Mental Status Examination (MMSE)

Planned enrollment: 60 (estimated).

Where

Recruiting US sites

  • Brigham and Women's Hospital / Dana-Farber Cancer Institute, Boston, Massachusetts

Site status as of Oct 30, 2026. Check the live record before contacting a site.

Sources

Where this comes from

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Sep 7, 2026. Public record; not medical advice.

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