Actively Recruiting
Intracavitary Carrier-embedded Cs131 Brachytherapy for Recurrent Brain Metastases: a Randomized Phase II Study
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-01-13
103
Participants Needed
6
Research Sites
309 weeks
Total Duration
On this page
Sponsors
M
Memorial Sloan Kettering Cancer Center
Lead Sponsor
G
GT Medical Technologies, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 would like to see whether Cs-131 prevents brain tumors from growing back after surgery.The researchers will compare Cs-131 brachytherapy (which occurs during brain surgery) with the usual approach of brain surgery without brachytherapy. The researchers will compare both the effectiveness and safety of the two approaches.
CONDITIONS
Official Title
Intracavitary Carrier-embedded Cs131 Brachytherapy for Recurrent Brain Metastases: a Randomized Phase II Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients 18 years of age or older who can give consent
- Scheduled for elective craniotomy to remove a previously irradiated brain metastasis with suspected viable disease
- Anticipated to achieve gross-total or near-total (≥95%) tumor removal
- Karnofsky Performance Status score of 70 or higher
- Able to undergo brain MRI with gadolinium contrast
You will not qualify if you...
- Unable to tolerate MRI or CT imaging
- Pregnant or positive pregnancy test within 30 days before surgery
- Women who cannot agree to avoid breastfeeding for at least 12 weeks after the procedure
- Diagnosis of leptomeningeal carcinomatosis or more than 5 additional active or untreated central nervous system lesions (totaling more than 6 active lesions)
- Prior irradiation exceeding 100 Gy equivalent dose to the implant site
- Tumor margin touching brainstem or optic nerves
- Previous infection at the surgical site, current active systemic infection needing treatment, or immunodeficiency
- Need for urgent surgery before brachytherapy can be provided
- Intraoperative pathology showing less than 5% viable metastatic disease
AI-Screening
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Trial Site Locations
Total: 6 locations
1
Baptist Health South Florida
Miami, Florida, United States, 33143
Actively Recruiting
2
Memorial Sloan Kettering at Basking Ridge (Consent Only)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
3
Memorial Sloan Kettering Monmouth (Consent Only)
Middletown, New Jersey, United States, 07748
Actively Recruiting
4
Memorial Sloan Kettering Commack (Consent Only)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
6
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
N
Nelson Moss, MD
CONTACT
B
Brandon Imber, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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