Alpha Radiation Emitters Device for the Treatment of Squamous Cell Carcinoma (DaRT)

Not Applicable

Completed

• Conditions: Skin Squamous Cell Carcinoma

• Registration Number: NCT03353077
• Lead Sponsor: Alpha Tau Medical LTD.

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).

Study Timeline

• Study First Submitted: 2017-11-15
• Study Start: 2017-11-21
• Study First Submitted QC: 2017-11-22
• Study First Posted: 2017-11-27
• Primary Completion: 2019-07-14
• Study Completion: 2019-07-14
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-09
• Last Update Posted: 2021-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Reduction in Tumor size	30-45 days post seed insertion	The reduction in tumor size 30-45 days after DaRT insertion
Adverse Events	30-45 days post seed insertion	The incidence, severity and frequency of all Adverse Events

Secondary Outcome Measures

Name	Time	Method
Percent of NecroticTissue	30-45 days post seed insertion	Percent of necrotic tissue in the tumor 30-45 days after DaRT insertion

Trial Locations

Locations (1)

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.); 🇮🇹 Meldola, Italy