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

Skin Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04068155
• Other study ID #: CTP-MCT-00
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: January 2025

Study information

• Verified date: July 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 Malignant Cutaneous Tumors

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cutaneous Metastasis
• Cutaneous Tumor
• Neoplasm Metastasis
• Skin Cancer
• Skin Neoplasms

Intervention

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

Locations

Country	Name	City	State
France	CHU Grenoble Alpes	Grenoble
France	Centre Léon Bérard	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Alpha Tau Medical LTD.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	Tumor volume	Assessment of the reduction in tumor volume based on imaging tests	up to 9-11 weeks
Secondary	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
Secondary	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
Secondary	Disease-Free Survival (DFS) rate	Assessment of Disease-Free Survival	up to 24 months
Secondary	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