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

NCT04068155 | Recruiting

• 1 other identifier: CTP-MCT-00
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Skin Cancer; Cutaneous Tumor; Cutaneous Metastasis

Keywords

Squamous Cell Carcinoma; Basal Cell Carcinoma; Skin Cancer; Skin Metastasis; Superficial Sarcoma; Alpha Radiation; Cutaneous Lesion; Brachytherapy; Radiotherapy; Lentigo maligna melanoma; Carcinosarcom; scalp cancer; Lip cancer; Eyelid cancer; SCC

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Tumor volume

  up to 9-11 weeks

• DaRT seeds placement

  Day of DaRT insertion procedure

• Change in quality of life as assessed by the Skindex-16 questionnaire

  up to 9-11 weeks

• Disease-Free Survival (DFS) rate

  up to 24 months

• Change in quality of life as assessed by the Skin Cancer Index (SCI) questionnaire

  up to 9-11 weeks

Other Outcomes (1)

• Adverse Events

  up to 24 months

Study Arms (1)

DaRT Seeds Intratumoral Diffusing alpha-emitters

EXPERIMENTAL

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

Interventions

DaRT- Diffusing Alpha-emitters Radiation Therapy DEVICE

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

DaRT Seeds Intratumoral Diffusing alpha-emitters

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Alpha Tau Medical LTD.: lead

Study Sites (2)

CHU Grenoble Alpes

Grenoble, 38700, France

RECRUITING

Centre Léon Bérard

Lyon, 69008, France

RECRUITING

MeSH Terms

Conditions

Skin Neoplasms; Carcinoma, Squamous Cell; Carcinoma, Basal Cell; Lip Neoplasms; Eyelid Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell; Neoplasms, Basal Cell; Mouth Neoplasms; Head and Neck Neoplasms; Lip Diseases; Mouth Diseases; Stomatognathic Diseases; Facial Neoplasms; Eye Neoplasms; Eye Diseases; Eyelid Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liron Dimnik

CONTACT

+972-2-373-7000; LironD@alphatau.com

Amnon Gat

CONTACT

Amnong@alphatau.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: August 28, 2019
• Study Start: April 1, 2022
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: November 22, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)