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

NCT ID: NCT05135052

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-17
• Study Completion Date: 2027-05-15

Brief Summary

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.

Conditions

Non-melanoma Skin Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment arm

Treatment with Rhenium-SCT, Single treatment.

Group Type: EXPERIMENTAL

Rhenium-SCT

Intervention Type: DEVICE

Rhenium-SCT irradiation device

Interventions

Rhenium-SCT

Rhenium-SCT irradiation device

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

OncoBeta Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gerhard Dr Dahlhoff, MD

Role: STUDY_DIRECTOR

Oncobeta GmbH

Locations

Genesis Care Health Hub at RNS

Sydney, New South Wales, Australia

John Flynn Hospital

Tugun, Queensland, Australia

Hollywood Private

Perth, Western Australia, Australia

Klinik Ottakring

Ottakring, , Austria

Rostock University Hospital

Rostock, , Germany

Steve Beko Hospital

Pretoria, , South Africa

Kings College Hospital London

London, , United Kingdom

Countries

Australia; Austria; Germany; South Africa; United Kingdom

Other Identifiers

OB-RHSCT-101

Identifier Type: -

Identifier Source: org_study_id