To evaluate the efficacy of personalized irradiation with Rhenium /Yttrium-Skin Cancer Therapy (SCT)
Design
This is an interventional clinical trial with a single group design of 20 patients, performed between July 2023 and March 2025 that will be followed after the treatment session.
Settings and conduct
Patients are selected and justified in the nuclear medicine center of the Persian Gulf Hospital at Bushehr. The consent form is obtained and the one-session treatment will be performed with Rhenium /Yttrium radioactive skin patch. The lesion needed to be outlined with a demographic pen using accurate visual examination, including a safety margin of approximately 5mm around it.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age >=18 years, Stage I or II BCC or SCC, Confirmed Histology (with the depth of lesion noted), Subjects able and willing to comply with the requirements of the study.
Exclusion criteria: 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), Malignant melanoma systemic therapy ongoing, pregnancy and/or Lactation.
Intervention groups
We are going to use a specially designed radioactive skin patch to evaluate the efficacy of personalized irradiation with Rhenium /Yttrium-Skin Cancer Therapy in the treatment of Stage I or II Basal or Squamous cell carcinoma.
Main outcome variables
Complete remission of skin cancer lesions.
The technique proposed by radioactive skin patch offers the ability to treat almost every anatomical location, as well as the possibility to treat several lesions at once, leading to a great advantage if compared with conventional treatments.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210612051548N6
Registration date:2023-05-24, 1402/03/03
Registration timing:prospective
Last update:2023-05-24, 1402/03/03
Update count:0
Registration date
2023-05-24, 1402/03/03
Registrant information
Name
Majid Assadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 77 3332 0361
Email address
assadipoya@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-06, 1402/04/15
Expected recruitment end date
2025-03-19, 1403/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Personalized Irradiation with Rhenium/Yttrium-Skin Cancer Therapy (SCT) for the Treatment of Non-Melanoma Skin Cancer
Public title
Rhenium/Yttrium-Skin Cancer Therapy for the Treatment of Non-Melanoma Skin Cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Bushehr province university of medical sciences
Street address
Bushehr University of Medical Science, Moallem Street, Bushehr, Iran
City
Bushehr
Province
Boushehr
Postal code
45654775
Approval date
2023-02-06, 1401/11/17
Ethics committee reference number
IR.BPUMS.REC.1401.210
Health conditions studied
1
Description of health condition studied
Non-melanoma Skin Cancer
ICD-10 code
C44
ICD-10 code description
Other and unspecified malignant neoplasm of skin
Primary outcomes
1
Description
the longest diameter of the lesion
Timepoint
6 months
Method of measurement
Visual RECIST (Response Evaluation Criteria in Solid Tumours) tool
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients 18 years and older with stage I or II BCC (Basal Cell Carcinoma) or SCC (Squamous cell carcinoma)
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Nuclear Medicine Center, Khalig-e-Fars Hospital
Full name of responsible person
Majid Assadi
Street address
Khalig-e-Fars Hospital, Taleghani Street
City
Bushehr
Province
Boushehr
Postal code
45654775
Phone
+98 77 3332 0361
Email
assadipoya@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Akram Farhadi
Street address
Vice-Chancellor for Research and Technology of Bushehr University of Medical Sciences, Salman-e-Farsi Blvd, Bushehr, Iran.
City
Bushehr
Province
Boushehr
Postal code
45654775
Phone
+98 77 3345 0178
Fax
Email
ak.farhadi@gmail.com
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Boushehr University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Majid Assadi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Nuclear Medicine
Street address
The Persian Gulf Nuclear Medicine Research Center, Bushehr University of Medical Sciences,Moallem Street, Bushehr, Iran
City
Bushehr
Province
Boushehr
Postal code
45654775
Phone
+98 77 3332 0361
Fax
+98 77 3332 0361
Email
assadipoya@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Majid Assadi
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Nuclear Medicine
Street address
The Persian Gulf Nuclear Medicine Research Center, Bushehr University of Medical Sciences,Moallem Street, Bushehr, Iran
City
Bushehr
Province
Boushehr
Postal code
45654775
Phone
+98 77 3332 0361
Fax
+98 77 3332 0361
Email
assadipoya@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Narges Jokar
Position
Research Instructor
Latest degree
Master
Other areas of specialty/work
Medical Physics
Street address
The Persian Gulf Nuclear Medicine Research Center, Bushehr University of Medical Sciences,Moallem Street, Bushehr, Iran
City
Bushehr
Province
Boushehr
Postal code
45654775
Phone
+98 77 3332 0361
Fax
+98 77 3332 0361
Email
narges.jokar69@gmail.com
Web page address
https://pgnmrc.bpums.ac.ir/fa/index.aspx
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available