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

Primary Purpose

Skin Cancer, Cutaneous Tumor, Cutaneous Metastasis

Status

Recruiting

Phase

Not Applicable

Locations

France

Study Type

Interventional

Intervention

DaRT- Diffusing Alpha-emitters Radiation Therapy

About this trial

This is an interventional treatment trial for Skin Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

CHU Grenoble AlpesRecruiting
Centre Léon BérardRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DaRT Seeds Intratumoral Diffusing alpha-emitters

Arm Description

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

Outcomes

Primary Outcome Measures

The objective response rate to DaRT treatment

Assessment of tumor response rate using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)

Secondary Outcome Measures

Tumor volume

Assessment of the reduction in tumor volume based on imaging tests

DaRT seeds placement

Assessment of the DaRT seed placement by localization of the DaRT seed in the tumor using CT imaging

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

Disease-Free Survival (DFS) rate

Assessment of Disease-Free Survival

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.

Full Information

NCT ID

NCT04068155

First Posted

August 19, 2019

Last Updated

July 23, 2023

Sponsor

Alpha Tau Medical LTD.

1. Study Identification

Unique Protocol Identification Number

NCT04068155

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 1, 2022 (Actual)

Primary Completion Date

January 2024 (Anticipated)

Study Completion Date

January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Alpha Tau Medical LTD.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

DaRT Seeds Intratumoral Diffusing alpha-emitters

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

DaRT- Diffusing Alpha-emitters Radiation Therapy

Intervention Description

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

Primary Outcome Measure Information:

Title

The objective response rate to DaRT treatment

Description

Assessment of tumor response rate using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)

Time Frame

up to 9-11 weeks

Secondary Outcome Measure Information:

Title

Tumor volume

Description

Assessment of the reduction in tumor volume based on imaging tests

Time Frame

up to 9-11 weeks

Title

DaRT seeds placement

Description

Assessment of the DaRT seed placement by localization of the DaRT seed in the tumor using CT imaging

Time Frame

Day of DaRT insertion procedure

Title

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

Description

Assessment of patient reported health-related Quality of Life (QoL) outcomes using the Skindex-16 questionnaire

Time Frame

up to 9-11 weeks

Title

Disease-Free Survival (DFS) rate

Description

Assessment of Disease-Free Survival

Time Frame

up to 24 months

Title

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

Description

Assessment of patient reported health-related Quality of Life (QoL) outcomes using the Skin Cancer Index (SCI) questionnaire.

Time Frame

up to 9-11 weeks

Other Pre-specified Outcome Measures:

Title

Adverse Events

Description

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.

Time Frame

up to 24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Liron Dimnik

Phone

+972-2-373-7000

LironD@alphatau.com

First Name & Middle Initial & Last Name or Official Title & Degree

Amnon Gat

Amnong@alphatau.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dr Pascal POMMIER

Organizational Affiliation

Centre Leon Berard

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Pr Jean Michel HANNOUN LEVI

Organizational Affiliation

Antoine Lacassagne Cancer Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Dr Camille VERRY

Organizational Affiliation

University Hospital, Grenoble

Official's Role

Principal Investigator

Facility Information:

Facility Name

CHU Grenoble Alpes

City

Grenoble

ZIP/Postal Code

38700

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

M. Camille Verry, MD

Phone

33 (0) 476765435

cverry@chu.grenoble.fr

Facility Name

Centre Léon Bérard

City

Lyon

ZIP/Postal Code

69008

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

POMMIER Pascal, MD

Phone

33 (0) 478785166

pascal.pommier@lyon.unicancer.fr

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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