NCT04690348
Intracavitary Carrier-embedded Cs131 Brachytherapy for Recurrent Brain Metastases: a Randomized Phase II Study
Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatmentMemorial Sloan Kettering Cancer CenterInvestigator-initiated
~103 participants
Updated 2026-06-04 on ClinicalTrials.gov
What's tested:CraniotomyCesium-131 brachytherapy
At a glance
Recruiting sites
0 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
freedom from local progression
Measured over 9 months following surgery
Conditions
Where it's being run
6 sites across 3 statesNew York3
New Jersey2
Florida1
Study leadership
- Nelson Moss, MD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Do you actually qualify for this trial?
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Eligibility criteria
Inclusion
Adult patients ≥ 18 years of age who are capable of giving consent
Undergoing elective craniotomy for resection of a previously-irradiated brain metastasis with suspicion for viable disease at the time of consent, and anticipated achievement of gross-total or near-total (\>/=95%) resection
Karnofsky Performance Status score (KPS) of ≥70
Ability to undergo brain MRI with gadolinium
Exclusion
Unable to tolerate MRI or CT imaging
Pregnancy (patients must have a negative pregnancy test within 30 days of the operation)
Women must agree to not breastfeed for at least 12 weeks after the procedure (lactating and discarding in that interval allowable)
Diagnosis of leptomeningeal carcinomatosis or \>5 additional active or untreated CNS lesions for a total of \>6 active lesions
Prior irradiation (EQD2) in excess of 100 Gy to site of implant, using an α/β of 2
Apposition of tumor margin to brainstem or optic apparatus
Previous infection within the operative field, current active systemic infection requiring systemic therapy, or immunodeficiency
Urgent surgery required prior to availability of brachytherapy
Patients will be excluded if intraoperative pathology is not consistent with \>/=5% viable metastatic disease.
What this trial measures
- freedom from local progression9 months following surgery
With a contrast enhanced brain MRI scan. Treatment response will be determined based on the Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria.