Language: BG BG
← Back to results
Active (not recruiting) Not applicable NCT05135052

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

No applicable phase (e.g. observational)
Conditions: Non-melanoma Skin Cancer

Sponsor: OncoBeta Therapeutics

trial.available_in: БГ
Overview
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.
Who can participate
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
Locations 4
Australia (1)
Genesis Care Health Hub at RNS
Sydney , New South Wales
Germany (1)
Rostock University Hospital
Rostock
South Africa (1)
Steve Beko Hospital
Pretoria
United Kingdom (1)
Kings College Hospital London
London
Technical details
Status
Active (not recruiting)
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
17.01.2022
Completion date
15.05.2027
Registry ID
NCT05135052
Source
anzctr
trial.inquiry_btn

Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.