Intracavitary Carrier-embedded Cs131 Brachytherapy for Recurrent Brain Metastases: a Randomized Phase II Study
NCT ID: NCT04690348
Last Updated: 2026-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
103 participants
INTERVENTIONAL
2020-12-24
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Resection without brachytherapy
Patients will undergo craniotomy.
Craniotomy
Craniotomy
Resection plus brachytherapy
Patients will undergo craniotomy and patients in the treatment arm will undergo implantation of Cesium 131 brachytherapy in coordination with the radiation oncologist.
Craniotomy
Craniotomy
Cesium-131 brachytherapy
Intracavitary Cesium-131 brachytherapy
Interventions
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Craniotomy
Craniotomy
Cesium-131 brachytherapy
Intracavitary Cesium-131 brachytherapy
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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.
18 Years
ALL
No
Sponsors
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GT Medical Technologies, Inc.
INDUSTRY
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Nelson Moss, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Baptist Health South Florida
Miami, Florida, United States
Memorial Sloan Kettering at Basking Ridge (Consent Only)
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (Consent Only)
Middletown, New Jersey, United States
Memorial Sloan Kettering Commack (Consent Only)
Commack, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States
Countries
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Central Contacts
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Brandon Imber, MD
Role: CONTACT
Facility Contacts
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Matthew Hall, MD
Role: primary
Nelson Moss, MD
Role: primary
Nelson Moss, MD
Role: primary
Nelson Moss, MD
Role: primary
Nelson Moss, MD
Role: primary
Brandon Imber, MD
Role: backup
Nelson Moss, MD
Role: primary
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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20-542
Identifier Type: -
Identifier Source: org_study_id
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