Alpha Radiation Emitters Device for the Treatment of Cutaneous, Mucosal and Superficial Soft Tissue Neoplasia (DaRT)

• ClinicalTrials.gov Identifier: NCT03886181
• Recruitment Status: Recruiting
• First Posted: March 22, 2019
• Last Update Posted: June 15, 2022
• Sponsor: Alpha Tau Medical LTD.
• Information provided by (Responsible Party): Alpha Tau Medical LTD.

Study Description

Brief Summary:

A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for superficial cutaneous, mucosal or soft tissue neoplasia

Condition or disease	Intervention/treatment	Phase
Skin Cancer; Mucosal Neoplasm of Oral Cavity; Soft Tissue Neoplasm	Device: Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)	Not Applicable

Detailed Description:

This will be a prospective, open label, single arm, controlled study, assessing the safety and efficacy of diffusing alpha emitters radiation therapy (DaRT) delivered through radioactive seeds inserted into the tumor.

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.

Superficial lesions with histopathological confirmation of malignancy will be treated using DaRT seeds.

Reduction in tumor volume and evaluation the percent of necrotic tissue in the tumor 30-45 days after DaRT seeds insertion (15-30 days after seed removal) will be assessed. Safety will be assessed by the cumulative incidence, worst severity and frequency of adverse events (AEs) observed including the follow-up period.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 35 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Safety and Preliminary Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters on Cutaneous, Mucosal and Superficial Soft Tissue Neoplasia
• Actual Study Start Date: July 8, 2021
• Estimated Primary Completion Date: June 2023
• Estimated Study Completion Date: September 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: DaRT Seeds; Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds	Device: 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.

Outcome Measures

Primary Outcome Measures :

1. Evaluate the safety of the DaRT treatment [ Time Frame: 5-7 weeks after DaRT seed insertion. ]
   The study primary objective is to evaluate the safety of the DaRT treatment in terms of incidence of device related Serious Adverse Events (SAE).

Secondary Outcome Measures :

1. Evaluation the effectiveness of the treatment. [ Time Frame: Tumor volume will be measured during screening, 5 and 30-45 days post DaRT after treatment using CT. ]
   Evaluation on the effectiveness of the DaRT treatment, in terms of tumor volume reduction.

Other Outcome Measures:

1. Evaluate the effectiveness of the DaRT treatment, in terms of percent of necrotic [ Time Frame: 15-30 days after removal of DaRT seeds. ]
   Evaluate the effectiveness of the DaRT treatment, in terms of percent of necrotic tissue present in the remaining tumor tissue surgically removed 15-30 days after removal of DaRT seeds.

Eligibility Criteria

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

Criteria

Inclusion Criteria:

• Subjects with histopathological confirmation of cutaneous and/or mucosal and/or superficial soft tissue malignant neoplasia.
• Subjects with a tumor size ≤ 5 centimeters in the longest diameter.
• Subjects' age is over 18 years old.
• Subjects' ECOG Performance Status Scale is < 2.
• Subjects' life expectancy is more than 6 months.
• Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test.
• Subjects are able and willing to sign an informed consent form.

Exclusion Criteria:

• Subject has a tumor with a maximal diameter > 5 centimeters.
• Subjects' ECOG Performance Status Scale is > 3.
• Subject has a tumor of Keratoacanthoma histology.
• Patients with moribund diseases, e.g., autoimmune diseases, vasculitis, etc.
• Patients under systemic immunosuppressive and/or corticosteroid treatment. Patients taking corticosteroid inhalers are eligible.

Contacts and Locations

Contacts

Contact: Liron Dimnik; +972-2-373-7000; LironD@alphatau.com

Locations

Italy

IRCCS Istituto Dermatologico S. Gallicano, IFO - Istituti Fisioterapici Ospitalieri - Dermatologia Oncologica e Prevenzione; Recruiting

Rome, Lazio, Italy

Contact: Laura Eibenschuz, MD

Principal Investigator: Laura Eibenschuz, MD

Sponsors and Collaborators

Alpha Tau Medical LTD.

Investigators

• Principal Investigator: Laura Eibenschuz, MD; IFO S. Gallicano

More Information

• Responsible Party: Alpha Tau Medical LTD.
• ClinicalTrials.gov Identifier: NCT03886181
• Other Study ID Numbers: CTP-CMN-01
• First Posted: March 22, 2019
• Last Update Posted: June 15, 2022
• Last Verified: June 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Alpha Tau Medical LTD.:

Squamous Cell Carcinoma; SCC; Skin Cancer; Skin metastasis; HNSCC; Carcinoma, Squamous; CMN; Basal cell carcinoma; Superficial sarcoma; Kaposi sarcoma; Alpha radiation; Cutaneous lesion; Tongue cancer; Lip cancer

Additional relevant MeSH terms:

Neoplasms; Skin Neoplasms; Soft Tissue Neoplasms; Mouth Neoplasms; Neoplasms by Site; Skin Diseases; Head and Neck Neoplasms; Mouth Diseases; Stomatognathic Diseases