Recruiting
Phase 2

Observational Study

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT07053033

Conditions

Brain Metastases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Surgery

LITT

Study Details

Brief summary:

standard paradigm for management of patients who present with concern for recurrence of brain metastases following initial stereotactic radiosurgery (SRS).

Conditions

Brain Metastases

Study ID

NCT07053033

Start date

Jan 1, 2026

Status verified date

Mar, 2026

Completion date

Dec 30, 2028

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Ability to understand and the willingness to sign a written informed consent document.
  • Willingness to comply with all study procedures and availability for the duration of the study.
  • Age ≥18 years. Because no dosing or adverse event data are currently available on the use of SRS2, children are excluded from this study.
  • Karnofsky performance status ≥ 60.
  • Radiographic concern for progression of a solid tumor brain metastasis that has received prior stereotactic radiosurgery ≥ 3 months prior to study enrollment.
  • Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension as ≥5 mm with MRI scan.
  • Have active tumor on pathology from surgery/LITT for this lesion.
  • Able to safely undergo MRI imaging.
  • Acceptable candidate for SRS2 per treating physician and multidisciplinary conference consensus.
  • Have no radiographic evidence of leptomeningeal disease on radiology report or neuro-radiologist review.
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.

Exclusion Criteria:

  • Patients with brain metastases from hematologic malignancies due to significant differences in radiosensitivity and treatment paradigms.
  • Patients with psychiatric illness/social situations that would limit compliance with study requirements.
  • Pregnant women are excluded from this study because radiation has the potential for teratogenic or abortifacient effects. All female patients between the onset of menses and 55 years will receive a pregnancy test prior to SRS2 unless the patient presents with an applicable exclusionary factor which may be one of the following:
  • Postmenopausal (no menses in greater than or equal to 12 consecutive months).
  • History of hysterectomy or bilateral salpingo-oophorectomy.
  • Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
  • History of bilateral tubal ligation or another surgical sterilization procedure.

Study Design

Enrollment

155 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Eligible for surgery or LITT-Surveillance

Patients will be randomized in a 1:1 manner to close surveillance versus SRS2.

experimental: Eligible for surgery or LITT-SRS2

Patients will be randomized in a 1:1 manner to close surveillance versus SRS2.

experimental: Ineligible for surgery or LITT-SRS2

Patients will be randomized in a 1:1 manner to close surveillance versus SRS2.

Interventions

Surgery

Participants will initially undergo craniotomy and surgical resection of lesions or LITT

LITT

Participants will undergo 4-core stereotactic biopsy and LITT by experienced neurosurgeons with specific expertise.

Primary outcome measure

  • Safety and Adverse Events (AEs) [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts and Locations

Central contacts

Subha Perni, MD

713-563-2543sperni@mdanderson.org

Locations

The University of Texas M. D. Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Subha Perni, MD

713-563-2543sperni@mdanderson.org

Principal Investigator:

Subha Perni, MD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Mar 9, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-03-09.