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

Last updated: May 9, 2025
Sponsor: OncoBeta Therapeutics
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Skin Cancer

Treatment

Rhenium-SCT

Clinical Study ID

NCT05135052
OB-RHSCT-101
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Stage I or II BCC or SCC (SCC Well to Moderately Differentiated), and clinicallynode 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 3lesions are not excluded from the study, however 3 target lesions are determined forstudy 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 appropriateclinically by treating clinician

  9. Subjects who are not deemed suitable for surgery, for example due to tumourlocation, performance status or other comorbidities as deemed relevant by thetreating clinician

  10. Patients who may have declined Surgery and/or fractionated Radiation Therapy

Exclusion

Exclusion Criteria:

  1. Inability to personally provide written informed consent or to understand andcollaborate 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 andlower), Vermillion lip

Study Design

Total Participants: 210
Treatment Group(s): 1
Primary Treatment: Rhenium-SCT
Phase:
Study Start date:
January 17, 2022
Estimated Completion Date:
May 15, 2027

Connect with a study center

  • Genesis Care Health Hub at RNS

    Sydney, New South Wales 2065
    Australia

    Site Not Available

  • John Flynn Hospital

    Tugun, Queensland 4224
    Australia

    Site Not Available

  • Hollywood Private

    Perth, Western Australia 6009
    Australia

    Site Not Available

  • Klinik Ottakring

    Ottakring, 1160
    Austria

    Site Not Available

  • Rostock University Hospital

    Rostock, 18057
    Germany

    Site Not Available

  • Steve Beko Hospital

    Pretoria, 0001
    South Africa

    Site Not Available

  • Kings College Hospital London

    London,
    United Kingdom

    Site Not Available

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