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

Last updated: March 30, 2022
Sponsor: OncoBeta Therapeutics
Overall Status: Active - Recruiting

Phase

N/A

Condition

Skin Cancer

Treatment

N/A

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 clinically nodenegative 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 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

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 and lower),Vermillion lip

Study Design

Total Participants: 210
Study Start date:
January 17, 2022
Estimated Completion Date:
May 15, 2024

Connect with a study center

  • Genesis Care Health Hub at RNS

    Sydney, New South Wales 2065
    Australia

    Active - Recruiting

  • John Flynn Hospital

    Tugun, Queensland 4224
    Australia

    Active - Recruiting

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