Alpha Radiation Emitters Device for the Treatment of of Malignant Cutaneous Tumors

NCT ID: NCT04068155

Last Updated: 2024-11-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2025-01-31

Brief Summary

A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for Malignant Cutaneous Tumors

Detailed Description

This will be a prospective, open label, single arm, multi- center study, assessing the safety and effectiveness 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.

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

Reduction in tumor size 9-11 weeks following DaRT insertion will be assessed. Safety will be assessed by the frequency, severity and causality of all Adverse Events (AE).

Conditions

Skin Cancer; Cutaneous Tumor; Cutaneous Metastasis

Study Design

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

Study Groups

DaRT Seeds Intratumoral Diffusing alpha-emitters

An intratumoral insertion of securely fixed seeds loaded with Radium-224. The seeds release by recoil short-lived alpha-emitting atoms into the tumor.

Group Type: EXPERIMENTAL

DaRT- Diffusing Alpha-emitters Radiation Therapy

Intervention Type: DEVICE

Seed(s) loaded with Radium-224 for local intratumoral irradiation with the destructive power of alpha particles

Interventions

DaRT- Diffusing Alpha-emitters Radiation Therapy

Seed(s) loaded with Radium-224 for local intratumoral irradiation with the destructive power of alpha particles

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Subjects with histopathological confirmation of newly diagnosed (Cohort A) or locally recurrent (Cohort B) malignant cutaneous lesions of the following histopathologies:

• SCC
• BCC
• Lentigo maligna melanoma (Dubreuilh melanoma)
• Carcinosarcoma
• Acceptable tumor locations include the following:

• Skin (facial, scalp, extremities, torso)
• Lips
• Eyelids
• Subjects with a tumor size ≤ 7 centimeters in the longest diameter.
• Target lesion technically amenable for full tumor coverage with the Alpha DaRT seeds.
• Measurable disease according to RECIST v1.1.
• Subjects over 18 years old.
• Subjects' ECOG Performance Status Scale is < 2.
• Subjects' life expectancy is more than 6 months.
• Platelet count ≥100,000/mm3.
• International normalized ratio of prothrombin time ≤1.8.
• Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test.
• Subjects are willing to sign an informed consent form

Exclusion Criteria

• Subject has a tumor with histology of one of the following:

• Keratoacanthoma
• Merkel cell carcinoma
• Sarcoma other than carcinosarcoma
• Metastatic disease (according to the TNM staging system - M1 patients are excluded)
• Patients with significant comorbidities that the treating physician deems may conflict with the endpoints of the study (e.g., poorly controlled autoimmune diseases, vasculitis, etc.).
• Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.
• Volunteers participating in another interventional study in the past 30 days which might conflict with the endpoints of this study or the evaluation of response or toxicity of DaRT.
• High probability of protocol non-compliance (in opinion of investigator).
• Subjects not willing to sign an informed consent.
• Women who are pregnant or breastfeeding.

• 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

Principal Investigators

Dr Pascal POMMIER

Role: PRINCIPAL_INVESTIGATOR

Centre Leon Berard

Pr Jean Michel HANNOUN LEVI

Role: PRINCIPAL_INVESTIGATOR

Antoine Lacassagne Cancer Center

Dr Camille VERRY

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

CHU Grenoble Alpes

Grenoble, , France

Site Status: RECRUITING

Centre Léon Bérard

Lyon, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Liron Dimnik

Role: CONTACT

LironD@alphatau.com

+972-2-373-7000

Amnon Gat

Role: CONTACT

Amnong@alphatau.com

Facility Contacts

M. Camille Verry, MD

Role: primary

cverry@chu.grenoble.fr

33 (0) 476765435

POMMIER Pascal, MD

Role: primary

pascal.pommier@lyon.unicancer.fr

33 (0) 478785166

Other Identifiers

CTP-MCT-00

Identifier Type: -

Identifier Source: org_study_id