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

  • End date
    Dec 31, 2022
  • participants needed
  • sponsor
    Cancer Intelligence Care Systems, Inc.
Updated on 28 February 2022
skin lesion


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.

Condition Malignant Melanoma, Angiosarcoma
Treatment CICS-1 (investigational device),SPM-011(investigational drug)
Clinical Study IdentifierNCT04293289
SponsorCancer Intelligence Care Systems, Inc.
Last Modified on28 February 2022


Yes No Not Sure

Inclusion Criteria

Patients with primary malignant melanoma or angiosarcoma diagnosed histopathologically
Patients with superficial skin lesions whose maximum diameter of the target lesion is 15 cm or less
Patients with lesions that are lying 6 cm or less from the skin surface to the deepest part of the tumor
Patients with lesions in the head, neck, chest, or extremities
Patients who do not have apparent abnormal hematological and biochemical values in the latest screening test within 28 days of registration

Exclusion Criteria

Patients with obvious disseminated lesions
Patients who have undergone previous treatment of radiation therapy exceeding 75 Gy for the target lesion
Patients with active lesions / active multiple cancers in addition to the target lesion
Patients with infections that require systemic treatment
Patients with active implantable medical devices
Patients with a history of BNCT treatment
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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