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Craniotomy, Cesium-131 brachytherapy

Phase 2

Recurrent Brain Metastases | Unknown | Other |GT Biopharma, Inc.|Last Updated: Jan 13, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment103
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04690348Intracavitary Carrier-embedded Cs131 Brachytherapy for Recurrent Brain Metastases: a Randomized Phase II StudyPHASE2 RECRUITING 103Dec 24, 2020Dec 1, 2026Jan 13, 20266 United States
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Study Endpoints
Primary Endpoints
freedom from local progression
9 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.

Secondary Endpoints
wound complications
3 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Resection without brachytherapyACTIVE_COMPARATORPatients will undergo craniotomy.
Resection plus brachytherapyEXPERIMENTALPatients will undergo craniotomy and patients in the treatment arm will undergo implantation of Cesium 131 brachytherapy in coordination with the radiation oncologist.
Interventions
NameTypeDescription
CraniotomyPROCEDURECraniotomy
Cesium-131 brachytherapyRADIATIONIntracavitary Cesium-131 brachytherapy
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites6

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 (\>/...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT04690348studyFirstPostDate: changed