Brain surgery boost: radioactive seeds may keep tumors from returning
NCT ID NCT04690348
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether placing tiny radioactive seeds (Cs-131) in the brain during surgery can stop recurrent brain tumors from growing back. About 103 adults with previously treated brain metastases will be randomly assigned to receive either surgery alone or surgery plus this radiation implant. The goal is to see if the added radiation improves local tumor control without increasing complications.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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103 people
The number who actually took part.
- Started
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Dec 2020
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Baptist Health South Florida
Miami, Florida, 33143, United States
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Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
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Memorial Sloan Kettering Commack (Consent Only)
Commack, New York, 11725, United States
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Memorial Sloan Kettering Monmouth (Consent Only)
Middletown, New Jersey, 07748, United States
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Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553, United States
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Memorial Sloan Kettering at Basking Ridge (Consent Only)
Basking Ridge, New Jersey, 07920, United States
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