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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

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment103

FDA Designations

No designations recorded

Clinical trial landscape

Craniotomy, Cesium-131 brachytherapy · 1 trial · 1 indication

Phase 2 1
NCT04690348Intracavitary Carrier-embedded Cs131 Brachytherapy for Recurrent Brain Metastases: a Randomized Phase II StudyRecurrent Brain Metastases
RECRUITING103 Analytics
PHASE2RECRUITING
Intracavitary Carrier-embedded Cs131 Brachytherapy for Recurrent Brain Metastases: a Randomized Phase II Study
Recurrent Brain MetastasesUnlock trial analytics

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 to 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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Frequently asked questions about Craniotomy, Cesium-131 brachytherapy

What is Craniotomy, Cesium-131 brachytherapy used for?

Craniotomy, Cesium-131 brachytherapy is used for recurrent brain metastases. It is an investigational treatment being studied in a Phase 2 clinical trial for patients with this condition.

Who is developing Craniotomy, Cesium-131 brachytherapy?

GT Biopharma, Inc. (ticker: GTBP) is developing Craniotomy, Cesium-131 brachytherapy. The company is conducting a Phase 2 clinical trial to evaluate this treatment for recurrent brain metastases.

What phase is Craniotomy, Cesium-131 brachytherapy in?

Craniotomy, Cesium-131 brachytherapy is in Phase 2 clinical development. It is an investigational treatment and has not been approved by the FDA for recurrent brain metastases.

What clinical trials is Craniotomy, Cesium-131 brachytherapy in?

Craniotomy, Cesium-131 brachytherapy is being studied in trial NCT04690348, titled 'Intracavitary Carrier-embedded Cs131 Brachytherapy for Recurrent Brain Metastases: a Randomized Phase II Study.' This trial is recruiting 103 participants in the United States.

Is Craniotomy, Cesium-131 brachytherapy a randomized trial?

Yes, the Phase 2 clinical trial for Craniotomy, Cesium-131 brachytherapy is randomized and active-controlled. It is not double-blind, and it uses biomarker selection for patient enrollment.