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Boron Neutron Capture Therapy Using CICS-1 and SPM-011 for Malignant Melanoma and Angiosarcoma

NCT04293289 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-02-08

No results posted yet for this study

Summary

Among skin malignancies, patients with malignant melanoma or angiosarcoma are treated with BNCT using CICS-1 and SPM-011 (borofalan (10B)). Through this trial, safety and appropriate treatment dose will be determined.

Conditions

  • Malignant Melanoma
  • Angiosarcoma

Interventions

OTHER

CICS-1 (investigational device),SPM-011(investigational drug)

Intravenous administration of SPM-011 and neutron irradiation with CICS-1.

Sponsors & Collaborators

  • Stella Pharma Corporation

    collaborator INDUSTRY

  • Cancer Intelligence Care Systems, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-19
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • Japan

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04293289 on ClinicalTrials.gov