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NCT Number: NCT04690348

Intracavitary Carrier-embedded Cs131 Brachytherapy for Recurrent Brain Metastases: a Randomized Phase II Study

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Recurrent Brain Metastases Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Baptist Health South Florida, Miami, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Craniotomy

Procedure

Craniotomy

Cesium-131 brachytherapy

Radiation

Intracavitary Cesium-131 brachytherapy

Primary outcomes

  1. freedom from local progression

    Time frame: 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 outcomes

  1. wound complications

    Time frame: 3 months

    Physical examination including wound examination will be performed, and wound complications (including dehiscence, superficial/deep infection, CSF leak) will be recorded by the evaluating clinicians.

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Collaborators

  • GT Medical Technologies, Inc.

Registry information

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Dec 30, 2020
Registry last updated
Jun 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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