Rhenium-Skin Cancer Therapy (SCT) for the Treatment of Non-Melanoma Skin Cancer. (EPIC-Skin)

OncoBeta

Status: Active, not recruiting

Conditions: Non-melanoma Skin Cancer

Treatments: Device: Rhenium-SCT

Study type: Interventional

Funder types: Industry

Identifiers

NCT05135052

OB-RHSCT-101

Details and patient eligibility

About

Efficacy of Personalised Irradiation with Rhenium-Skin Cancer Therapy (SCT) for the treatment of non-melanoma skin cancer; a phase IV multi-centre, international, open label, single arm study.

Enrollment: 210 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Stage I or II BCC or SCC (SCC Well to Moderately Differentiated), and clinically node negative disease
2. Confirmed Histology, and with depth of lesion noted
3. Subjects with up to 3 lesions suitable to enter the study (subjects with more than 3 lesions are not excluded from the study, however 3 target lesions are determined for study evaluation only.)
4. Subjects able and willing to comply with the requirements of the study
5. Age >=18 years
6. Informed Consent signed by the subject consenting to undergo the study
7. Lesions up to 8cm2
8. Lesions with a depth up to 3mm confirmed on biopsy report AND deemed appropriate clinically by treating clinician
9. Subjects who are not deemed suitable for surgery, for example due to tumour location, performance status or other comorbidities as deemed relevant by the treating clinician
10. Patients who may have declined Surgery and/or fractionated Radiation Therapy

Exclusion criteria

1. Inability to personally provide written informed consent or to understand and collaborate throughout the study
2. Inability or unwillingness to comply with study requirements
3. Prior treatment with surgery or radiation therapy for their target lesion(s)
4. Depth of lesion greater than 3mm as defined by Biopsy and/or clinical assessment
5. Lupus and Scleroderma
6. Basal cell naevus syndrome, xeroderma, vitiligo and albinism
7. Prior laser at the tumour site
8. Malignant melanoma systemic therapy ongoing
9. Any ongoing treatment for malignancy, or in the last 4 weeks prior to study entry
10. A tumour affecting nerves or bony structures
11. Clinical concern of metastatic disease
12. Pregnancy and/or Lactation
13. Pathological exclusions: Perineural Invasion, Lymphovascular invasion
14. Anatomical exclusions: NMSC's of the Medial canthus, eyelid margin (upper and lower), Vermillion lip

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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210 participants in 1 patient group

Treatment arm

Experimental group

Description:

Treatment with Rhenium-SCT, Single treatment.

Treatment:

Device: Rhenium-SCT