Study on Using Cs-131 Brachytherapy During Surgery for Recurrent Brain Tumors

Sponsor: Memorial Sloan Kettering Cancer Center

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04690348

This clinical trial is testing whether a special type of radiation therapy, called Cs-131 brachytherapy, can help prevent brain tumors from returning after surgery. The study will compare the outcomes of patients who receive this treatment during surgery with those who have surgery alone.

Patient Parameters

Program Overview

The aim of this study is to determine if Cs-131 brachytherapy, a type of radiation treatment given during brain surgery, is effective in stopping brain tumors from coming back in patients with recurrent brain cancer. Researchers will compare the results of patients who receive Cs-131 brachytherapy during their surgery to those who only have the surgery without this additional treatment. The study will look at both the effectiveness and safety of these two approaches.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older who can give consent.
  • Scheduled for brain surgery to remove a previously treated brain tumor that may still have active cancer cells.
  • Expected to have most or all of the tumor removed during surgery.
  • Have a Karnofsky Performance Status score of 70 or higher, indicating they can care for themselves.
  • Able to have an MRI scan with a contrast dye called gadolinium.

Exclusion Criteria

  • Cannot have MRI or CT scans.
  • Pregnant women (a negative pregnancy test is required within 30 days before surgery).
  • Women must agree not to breastfeed for at least 12 weeks after the procedure.
  • Have a type of cancer that has spread to the lining of the brain or more than 5 active brain lesions.
  • Have had too much previous radiation to the area where the implant will be placed.
  • Tumor is too close to critical areas like the brainstem or optic nerves.
  • Have had an infection in the surgery area, an active infection needing treatment, or a weakened immune system.
  • Need urgent surgery before brachytherapy can be arranged.

Intraoperative Exclusion Criterion:

  • If during surgery, the tumor does not have at least 5% active cancer cells.

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