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

NCT ID: NCT03353077

Last Updated: 2021-03-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-21
• Study Completion Date: 2019-07-14

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).

Conditions

Skin Squamous Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Alpha DaRT

Alpha DaRT Seeds, Diffusing alpha-emitters Radiation Therapy.

Group Type: EXPERIMENTAL

Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)

Intervention Type: DEVICE

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.

Interventions

Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)

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.

Intervention Type: DEVICE

Other Intervention Names

DaRT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alpha Tau Medical LTD.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)

Meldola, , Italy

Countries

Italy

Other Identifiers

CTP-SCC-000

Identifier Type: -

Identifier Source: org_study_id