Pilot clinical study of boron neutron capture therapy on choroidal malignant melanoma

Phase 1

Not yet recruiting

• Conditions: Treatment-refractory, medium or large-sized primary choroidal malignant melanoma or choroidal malignant melanoma which recurred after radio-therapy

• Registration Number: JPRN-UMIN000029402
• Lead Sponsor: Osaka Medical College

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-10
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

Not provided

Exclusion Criteria

1.Patients who have systemic metastasis. 2.Pregnant woman or lactating woman 3.Patients with phenylketonuria 4.Patients who have mental illness and judged as difficult for participation of this clinical trial. 5.Patients who have the serum 5-S-CD value more than institutional reference value. 6.Patients who are judged to be inappropriate for participation in this study by an investigator or a test sharing physician for other reasons

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ocal control: Skin lesion of angiosarcoma should be photographed and measured on it, periodically. Major and minor axis should be recorded and judged as CR, PR, SD and PD for the assessment of local control.

Secondary Outcome Measures

Name	Time	Method
Expression of adverse events Evaluate adverse events and serious adverse events. Observed adverse events are evaluated based on Common Toxicity Criteria for Adverse Events v4.0 (CTCAE v4.0).