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

A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters on Squamous Cell Carcinoma

A unique approach for Skin Squamous Cell Carcinoma (SCC) treatment employing intratumoral diffusing alpha radiation emitter device

Study Overview

• Status: Completed
• Conditions: Skin Squamous Cell Carcinoma
• Intervention / Treatment: Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)

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 Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Meldola, Italy
    • Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori (I.R.S.T.)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Alpha DaRT; Alpha DaRT Seeds, Diffusing alpha-emitters Radiation Therapy.	Device: 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.; Other Names: DaRT

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of NecroticTissue	Percent of necrotic tissue in the tumor 30-45 days after DaRT insertion	30-45 days post seed insertion

Collaborators and Investigators

• Sponsor: Alpha Tau Medical LTD.

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2017
• Primary Completion (Actual): July 14, 2019
• Study Completion (Actual): July 14, 2019

Study Registration Dates

• First Submitted: November 15, 2017
• First Submitted That Met QC Criteria: November 22, 2017
• First Posted (Actual): November 27, 2017

Study Record Updates

• Last Update Posted (Actual): March 10, 2021
• Last Update Submitted That Met QC Criteria: March 9, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Skin SCC; Skin Carcinoma, Squamous
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Squamous Cell; Carcinoma; Carcinoma, Squamous Cell
• Other Study ID Numbers: CTP-SCC-000

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No