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IRCT20210612051548N6 IRCT 2023-05-24 Boushehr University of Medical Sciences Rhenium/Yttrium-Skin Cancer Therapy for the Treatment of Non-Melanoma Skin Cancer Efficacy of Personalized Irradiation with Rhenium/Yttrium-Skin Cancer Therapy (SCT) for the Treatment of Non-Melanoma Skin Cancer 2023-07-06 anticipated 20 Complete https://irct.ir/trial/70270 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. N/A Non-melanoma Skin Cancer. Intervention group: Patients 18 years and older with stage I or II BCC (Basal Cell Carcinoma) or SCC (Squamous cell carcinoma). Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is here is no further information
public Majid Assadi
The Persian Gulf Nuclear Medicine Research Center, Bushehr University of Medical Sciences,Moallem Street, Bushehr, Iran
Bushehr Iran (Islamic Republic of) 45654775 +98 77 3332 0361 assadipoya@yahoo.com Boushehr University of Medical Sciences scientific Majid Assadi
The Persian Gulf Nuclear Medicine Research Center, Bushehr University of Medical Sciences,Moallem Street, Bushehr, Iran
Bushehr Iran (Islamic Republic of) 45654775 +98 77 3332 0361 assadipoya@yahoo.com Boushehr University of Medical Sciences Iran (Islamic Republic of) Age >=18 years Stage I or II BCC (Basal Cell Carcinoma) or SCC (Squamous Cell Carcinoma) Confirmed Histology (with depth of lesion noted) 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.) Subjects able and willing to comply with the requirements of the study Lesions with a depth up to 3mm confirmed on biopsy report AND deemed appropriate clinically by treating clinician 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 Patients who may have declined Surgery and/or fractionated Radiation Therapy 18 years no limit Both Inability to personally provide written informed consent or to understand and collaborate throughout the study Inability or unwillingness to comply with study requirements Prior treatment with surgery or radiation therapy for their target lesion(s) Depth of lesion greater than 3mm as defined by Biopsy and/or clinical assessment Lupus and Scleroderma Prior laser at the tumour site Malignant melanoma systemic therapy ongoing Any ongoing treatment for malignancy, or in the last 4 weeks prior to study entry A tumour affecting nerves or bony structures pregnancy's and/or Lactation Anatomical exclusions: NMSC's of the Medial canthus, eyelid margin (upper and lower), Vermillion lip C44 Other and unspecified malignant neoplasm of skin Treatment - Devices Intervention group: Patients 18 years and older with stage I or II BCC (Basal Cell Carcinoma) or SCC (Squamous cell carcinoma) The longest diameter of the lesion. Timepoint: 6 months. Method of measurement: Visual RECIST (Response Evaluation Criteria in Solid Tumours) tool. Boushehr University of Medical Sciences Approved 2023-02-06 Research Ethics Committees of Bushehr province university of medical sciences Bushehr University of Medical Science, Moallem Street, Bushehr, Iran Bushehr Boushehr Iran (Islamic Republic of)