NCT07053033 Laser Interstitial Thermal Therapy (LITT) or Surgery and Adjuvant Reirradiation for Recurrent Brain Metastases (LaSAR BeaM)
| NCT ID | NCT07053033 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Brain Metastases |
| Study Type | INTERVENTIONAL |
| Enrollment | 155 participants |
| Start Date | 2026-01-01 |
| Primary Completion | 2026-12-30 |
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 155 participants in total. It began in 2026-01-01 with a primary completion date of 2026-12-30.
⚠ 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
standard paradigm for management of patients who present with concern for recurrence of brain metastases following initial stereotactic radiosurgery (SRS).
Eligibility Criteria
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.
Contact & Investigator
Subha Perni, MD
PRINCIPAL INVESTIGATOR
M.D. Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT07053033 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Brain Metastases. 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 NCT07053033 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 NCT07053033 currently recruiting?
Yes, NCT07053033 is actively recruiting participants. Contact the research team at sperni@mdanderson.org for enrollment information.
Where is the NCT07053033 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT07053033 clinical trial?
NCT07053033 is sponsored by M.D. Anderson Cancer Center. The principal investigator is Subha Perni, MD at M.D. Anderson Cancer Center. The trial plans to enroll 155 participants.