Status:
COMPLETED
Alpha Radiation Emitters Device for the Treatment of Squamous Cell Carcinoma (DaRT)
Lead Sponsor:
Alpha Tau Medical LTD.
Conditions:
Skin Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 14 2019
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03353077
Start Date
November 21 2017
End Date
July 14 2019
Last Update
March 10 2021
Active Locations (1)
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1
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)
Meldola, Italy