Tests boron neutron capture therapy in people with recurrent chest tumors
Tests BNCT radiation in adults with recurrent chest tumors that cannot be removed.
Plain-language title generated from the registry record
Registry title: Using CICS-1 and SPM-011 and ［18F］FBPA Commissioned by CICS and Sumitomo Heavy Industries and STELLA PHARMA
Key facts
- Where
- Osaka, JapanSee the site
- Phase
- Phase 1/2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 85 years old?
Source: NCT06603987, who can take part
Where in Japan
- ORIX Kouraibashi Bldg. 8F 3-2-7 Kouraibashi Chuo-kuOsaka, JapanNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Stella Pharma Corporation
- Trial code
- NCT06603987
- Record updated
- 19 November 2025
- Original description
To evaluate the safety and efficacy of Boron Neutron Capture Therapy (BNCT) in patients with recurrent thoracic solid tumors that are difficult to treat with standard radiation therapy or drug therapy and are unresectable. With "lung," "heart," "liver," "spinal cord," and "esophagus" as common risk organs in the treatment plan for BNCT using therapeutic CT to evaluate the safety and efficacy of BNCT in patients with unresectable and recurrent thoracic solid tumors which are difficult to treat with standard radiation and drug therapy.Read full original descriptionShow less
Phase I/II Basket Trial: Boron Neutron Capture Therapy (BNCT) Using CICS-1 and SPM-011 for Patients With Recurrent Solid Malignant Thoracic Tumors That Are Unresectable and Perceived Challenging to Treat With Standard Treatment
To evaluate the safety and efficacy of Boron Neutron Capture Therapy (BNCT) in patients with recurrent thoracic solid tumors that are difficult to treat with standard radiation therapy or drug therapy and are unresectable. With "lung," "heart," "liver," "spinal cord," and "esophagus" as common risk organs in the treatment plan for BNCT using therapeutic CT to evaluate the safety and efficacy of BNCT in patients with unresectable and recurrent thoracic solid tumors which are difficult to treat with standard radiation and drug therapy.
To evaluate the safety of ［18F］FBPA synthesized with MPS200FBPA. In addition, the usefulness of ［18F］FBPA-PET testing to determine the appropriateness of performing BNCT will be evaluated in an exploratory manner.
Inclusion: Written informed consent must be obtained from the subject; Patients with histopathological diagnosed malignant tumor (except cutaneous angiosarcoma); Measurable disease, as defined by RECIST v1.1; Patients diagnosed with recurrent malignant tumors that are unresectable and perceived challenging to treat with standard treatment; Patients with ECOG performance status score of 0 or 1.
Exclusion: Patients who received radiation therapy exceeding 65 Gy as a prior treatment for the target lesion; Any serious concomitant disease that precludes completion of the study treatment; Patients with remaining complications of Grade 3 or higher related to prior radiation therapy in the irradiation field; Patients with active disease or active double cancers other than target lesions; Patients with imaging findings that affect imaging evaluation of the tumor, such as ground-glass opacities.