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

Skin Cancer Clinical Trial

Official title:

A Safety and Preliminary Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters on Cutaneous, Mucosal and Superficial Soft Tissue Neoplasia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03886181
• Other study ID #: CTP-CMN-01
• Status: Recruiting
• Phase: N/A
• Start date: July 8, 2021
• Est. completion date: September 2024

Study information

• Verified date: June 2023
• Source: Alpha Tau Medical LTD.
• Contact: Liron Dimnik
• Phone: +972-2-373-7000
• Email: LironD[@]alphatau.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: September 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mouth Neoplasms
• Mucosal Neoplasm of Oral Cavity
• Neoplasms
• Skin Cancer
• Skin Neoplasms
• Soft Tissue Neoplasm
• Soft Tissue Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Italy	IRCCS Istituto Dermatologico S. Gallicano, IFO - Istituti Fisioterapici Ospitalieri - Dermatologia Oncologica e Prevenzione	Rome	Lazio

Sponsors (1)

Lead Sponsor	Collaborator
Alpha Tau Medical LTD.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evaluate the effectiveness of the DaRT treatment, in terms of percent of necrotic	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.	15-30 days after removal of DaRT seeds.
Primary	Evaluate the safety of the DaRT treatment	The study primary objective is to evaluate the safety of the DaRT treatment in terms of incidence of device related Serious Adverse Events (SAE).	5-7 weeks after DaRT seed insertion.
Secondary	Evaluation the effectiveness of the treatment.	Evaluation on the effectiveness of the DaRT treatment, in terms of tumor volume reduction.	Tumor volume will be measured during screening, 5 and 30-45 days post DaRT after treatment using CT.