Using CICS-1 and SPM-011 and ［18F］FBPA Commissioned by CICS and Sumitomo Heavy Industries and STE… (NCT06603987) | Clinical Trial Compass
By InvitationPhase 1/2
Using CICS-1 and SPM-011 and ［18F］FBPA Commissioned by CICS and Sumitomo Heavy Industries and STELLA PHARMA
Japan30 participantsStarted 2025-04-10
Plain-language summary
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.
Who can participate
Age range
18 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.