Recruiting
Phase 2

Stereotactic Radiation

Sponsor:

Ayal A. Aizer, MD

Code:

NCT07132190

Conditions

Brain Metastases, Adult

Brain Tumor - Metastatic

Brain Metastases From Non-small Cell Lung Cancer (NSCLC)

Brain Metastases From Extra-cranial Solid Tumors

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Linear accelerator-based stereotactic radiation for brain metastases using 0mm or 1mm PTV

Study Details

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.

Conditions

Brain Metastases, Adult

Brain Tumor - Metastatic

Brain Metastases From Non-small Cell Lung Cancer (NSCLC)

Brain Metastases From Extra-cranial Solid Tumors

Study ID

NCT07132190

Start date

Dec 30, 2025

Status verified date

Aug, 2026

Completion date

Sep, 2029

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 0mm PTV

0mm uncertainty margin

active comparator: 1mm PTV

1mm uncertainty margin

Interventions

Linear accelerator-based stereotactic radiation for brain metastases using 0mm or 1mm PTV

Linear accelerator-based stereotactic radiation for brain metastases using 0mm or 1mm PTV

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Locations

Brigham and Women's Hospital / Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

More Information

Sponsor

Ayal A. Aizer, MD

Last update posted

Sep 8, 2026

Last verified

Aug, 2026

Keywords

  • Brain Mets
  • Brain Metastases
  • Brain-directed stereotactic radiation
  • Brain radiation
  • Volatile Brain Metastases
  • Intracranial lesion
  • SRS
  • SRT
  • RANO
  • PTV
  • Planning Target Volume
  • Local Recurrence
  • Radiation Necrosis
  • Adaptive
  • VMAT
  • Volumetric Modulated Arc Therapy
  • Margin
  • Volatile
  • Rapid
  • Growth
  • Shift
  • neurocognitive
  • quality of life
  • survival
  • same day
  • randomized

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ayal A. Aizer, MD on 2026-09-08.