A Study of the Boron Neutron Capture Therapy (BNCT) Using B10 L-BPA in Malignant Brain Tumors

This Phase I/II study, titled 'A Phase I/II Study to Evaluate Safety and Efficacy of the Boron Neutron Capture Therapy (BNCT) using B10 L-BPA as Boron Carrier in Malignant Brain Tumors.', aims to assess the efficacy of B10 L-BPA with BNCT in patients with malignant brain tumors. The primary objective is to evaluate the safety and efficacy of BNCT with B10 L-BPA for malignant brain tumors treatment, using the Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1) as the standard for assessment.

Trial Details

NCT ID
NCT07003139
Phase
PHASE1 / PHASE2
Sponsor
China Medical University Hospital
Status
RECRUITING
Cancer Type
Brain Cancer
Interventions
  • B10 L-BPA Injection
Locations (sample)
  • Hsinchu, Taiwan|24.80361,120.96861
  • Taichung, Taiwan|24.1469,120.6839

Key Eligibility Criteria

  • Age of 18 years and older.
  • Patients with malignant brain tumors confirmed by histological and/or medical imaging, classified as WHO Grade 3 or 4 according to the World Health…
  • There must be a time interval ≥ 3 months between prior radiation therapy and the scheduled BNCT.
  • There must be a time interval ≥ 1 month between receipt of antitumor drugs and the scheduled BNCT.

For full eligibility, visit ClinicalTrials.gov.

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