Status:
RECRUITING
Intracavitary Carrier-embedded Cs131 Brachytherapy for Recurrent Brain Metastases: a Randomized Phase II Study
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
GT Medical Technologies, Inc.
Conditions:
Recurrent Brain Metastases
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to see if Cs-131 brachytherapy is effective in people with recurrent brain cancer who are scheduled to have brain surgery for removal of their tumor(s). The researchers wo...
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
- Intraoperative Exclusion Criterion:
- Patients will be excluded if intraoperative pathology is not consistent with \>/=5% viable metastatic disease.
Key Trial Info
Start Date :
December 24 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
103 Patients enrolled
Trial Details
Trial ID
NCT04690348
Start Date
December 24 2020
End Date
December 1 2026
Last Update
November 21 2025
Active Locations (6)
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1
Baptist Health South Florida
Miami, Florida, United States, 33143
2
Memorial Sloan Kettering at Basking Ridge (Consent Only)
Basking Ridge, New Jersey, United States, 07920
3
Memorial Sloan Kettering Monmouth (Consent Only)
Middletown, New Jersey, United States, 07748
4
Memorial Sloan Kettering Commack (Consent Only)
Commack, New York, United States, 11725