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

A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Malignant Cutaneous Tumors

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

Study Overview

• Status: Recruiting
• Conditions: Skin Cancer; Cutaneous Tumor; Cutaneous Metastasis
• Intervention / Treatment: Device: DaRT- Diffusing Alpha-emitters Radiation Therapy

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).

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amnon Gat; Email: Amnong@alphatau.com
• Study Contact Backup: Name: Liron Dimnik; Phone Number: +972-2-373-7000; Email: LironD@alphatau.com

Study Locations

• France
  • Grenoble, France, 38700
    • Recruiting
    • Chu Grenoble Alpes
    • Contact: M. Camille Verry, MD; Phone Number: 33 (0) 476765435; Email: cverry@chu.grenoble.fr
  • Lyon, France, 69008
    • Recruiting
    • Centre Leon Berard
    • Contact: POMMIER Pascal, MD; Phone Number: 33 (0) 478785166; Email: pascal.pommier@lyon.unicancer.fr

Participation Criteria

Eligibility Criteria

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

Description

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.

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: 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.	Device: DaRT- Diffusing Alpha-emitters Radiation Therapy; Seed(s) loaded with Radium-224 for local intratumoral irradiation with the destructive power of alpha particles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The objective response rate to DaRT treatment	Assessment of tumor response rate using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)	up to 9-11 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor volume	Assessment of the reduction in tumor volume based on imaging tests	up to 9-11 weeks
DaRT seeds placement	Assessment of the DaRT seed placement by localization of the DaRT seed in the tumor using CT imaging	Day of DaRT insertion procedure
Change in quality of life as assessed by the Skindex-16 questionnaire	Assessment of patient reported health-related Quality of Life (QoL) outcomes using the Skindex-16 questionnaire	up to 9-11 weeks
Disease-Free Survival (DFS) rate	Assessment of Disease-Free Survival	up to 24 months
Change in quality of life as assessed by the Skin Cancer Index (SCI) questionnaire	Assessment of patient reported health-related Quality of Life (QoL) outcomes using the Skin Cancer Index (SCI) questionnaire.	up to 9-11 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events	Assessment of the frequency, severity and causality of adverse events related and not related to the DaRT treatment. Adverse events will be assessed and graded according to Common Terminology and Criteria for adverse events (CTCAE) version 5.0.	up to 24 months

Collaborators and Investigators

• Sponsor: Alpha Tau Medical LTD.
• Investigators: Principal Investigator: Dr Pascal POMMIER, Centre Leon Berard; Principal Investigator: Pr Jean Michel HANNOUN LEVI, Antoine Lacassagne Cancer Center; Principal Investigator: Dr Camille VERRY, University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2022
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: August 19, 2019
• First Submitted That Met QC Criteria: August 22, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Estimated): November 22, 2024
• Last Update Submitted That Met QC Criteria: November 21, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Skin Cancer; Radiotherapy; Brachytherapy; Squamous Cell Carcinoma; SCC; Basal Cell Carcinoma; Lip cancer; Skin Metastasis; Superficial Sarcoma; Alpha Radiation; Cutaneous Lesion; Lentigo maligna melanoma; Carcinosarcom; scalp cancer; Eyelid cancer
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Neoplastic Processes; Skin Diseases; Neoplasm Metastasis; Skin Neoplasms
• Other Study ID Numbers: CTP-MCT-00

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