Skin Squamous Cell Carcinoma
Conditions
Keywords
Skin SCC, Skin Carcinoma, Squamous
Brief summary
A unique approach for Skin Squamous Cell Carcinoma (SCC) treatment employing intratumoral diffusing alpha radiation emitter device
Detailed description
This will be a prospective study, assessing the safety and effectiveness of intratumoral alpha radiation mediated treatment with Alpha DaRT seeds for the treatment of Skin Squamous Cell Carcinoma (SCC) tumors. Treatment will be delivered through radioactive sources (Alpha DaRT seeds) inserted into the tumors in the skin. This approach combines the advantages of local intratumoral irradiation of the tumor, as used in conventional brachytherapy, with the power of the alpha radiation emitting atoms, that will be introduced in quantities considerably lower than radiation therapy already used in patients. Lesions with histopathological diagnosis of squamous cell carcinoma will be studied. Reduction in tumor size 30-45 days after DaRT insertion will be assessed. Safety will be assessed by the incidence, severity and frequency of all Adverse Events (AE).
Interventions
An intratumoral insertion of a seed(s), loaded with Radium-224, securely fixed in the seeds. The seeds release by recoil into the tumor short-lived alpha-emitting atoms.
Sponsors
Alpha Tau Medical LTD.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single Group Assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects with histopathological confirmation of skin squamous cell carcinoma before surgical removal of the tumor. * Subjects with a tumor size ≤ 5 centimeters in the longest diameter (lesions without nodal spread). * Subjects' age is over 18 years old. * Subjects' ECOG Performance Status Scale is ≤ 2. * Subjects' life expectancy is more than 6 months. * Female subjects of childbearing age will have evidence of negative pregnancy test. * Subjects are willing to sign an informed consent form.
Exclusion criteria
* Subject has a tumor with a maximal diameter \> 5 centimeters. * Subject has an ulcerative lesion. * Subject has a tumor of Keratoacanthoma histology. * Subjects' ECOG Performance Status Scale is ≥ 3. * Patients with moribund diseases, e.g., autoimmune diseases, vasculitis, etc. * Patients under immunosuppressive and/or corticosteroid treatment. * Volunteers that participated in other studies in the past 30 days that might affect the evaluation of response or toxicity of DaRT. * Pregnant women. * Subjects not willing to sign an informed consent form.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 30-45 days post seed insertion | The incidence, severity and frequency of all Adverse Events |
| Reduction in Tumor size | 30-45 days post seed insertion | The reduction in tumor size 30-45 days after DaRT insertion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of NecroticTissue | 30-45 days post seed insertion | Percent of necrotic tissue in the tumor 30-45 days after DaRT insertion |
Countries
Italy
Outcome results
None listed