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Alpha Radiation Emitters Device (DaRT) for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia.

Primary Purpose

Skin Cancer, Mucosal Neoplasm of Oral Cavity, Soft Tissue Neoplasm

Status

Recruiting

Phase

Not Applicable

Locations

Israel

Study Type

Interventional

Intervention

Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)

About this trial

This is an interventional treatment trial for Skin Cancer focused on measuring Squamous Cell Carcinoma, SCC, Skin Cancer, Skin metastasis, HNSCC, Carcinoma, Squamous, CMN, Basal cell carcinoma, Superficial sarcoma, Kaposi sarcoma, Alpha radiation, Cutaneous lesion, Tongue cancer, Lip cancer

Eligibility Criteria

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

Inclusion Criteria:

Subjects with histopathological confirmation of primary or secondary malignant cutaneous neoplastic lesions, or oral cavity mucosal tumors, or superficial soft tissue sarcoma.
Subjects with a tumor size ≤ 7 centimeters in the longest diameter.
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.
Creatinine ≤1.9 mg/dL.
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 of Keratoacanthoma histology.
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

RAMBAM Health Care CampusRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DaRT Seeds

Arm Description

Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds

Outcomes

Primary Outcome Measures

Tumor response to DaRT

Assessment of the rate of malignant cutaneous, mucosal or superficial soft tissue tumors response using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)

Adverse Events

The incidence, frequency, severity and causality of acute adverse events related to the DaRT treatment

Secondary Outcome Measures

Assessment of the reduction in tumor volume

Assessment of the reduction in tumor volume based on CT / PET-CT measured tumor volume

DaRT seeds placement.

Assessment of the DaRT seeds placement by localization of the DaRT seeds in the tumor using CT imaging on the day of DaRT insertion.

Change in quality of life

Assessment of patient reported health-related Quality of Life outcome after DaRT, using QoL questionnaire Skindex-16 questionnaire score. An overall score ranging from 0 (best) to 100 (worst).

Change in quality of life

Assessment of patient reported health-related Quality of Life outcome after DaRT, using QoL questionnaire Skin Cancer Index (SCI) questionnaire score. An overall score ranging from 0 (best) to 100 (worst).

Full Information

NCT ID

NCT03889899

First Posted

March 21, 2019

Last Updated

July 23, 2023

Sponsor

Alpha Tau Medical LTD.

1. Study Identification

Unique Protocol Identification Number

NCT03889899

Brief Title

Alpha Radiation Emitters Device (DaRT) for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia.

Official Title

A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Malignant Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

October 21, 2020 (Actual)

Primary Completion Date

June 2024 (Anticipated)

Study Completion Date

September 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 superficial cutaneous, mucosal or soft tissue neoplasia

Detailed Description

This will be a prospective, open label, single arm, controlled study, assessing the safety and efficacy 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. Superficial lesions with histopathological confirmation of malignancy will be treated using DaRT seeds. Reduction in tumor size 70 days after DaRT insertion will be assessed. Safety will be assessed by the incidence, severity and frequency 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, Mucosal Neoplasm of Oral Cavity, Soft Tissue Neoplasm

Keywords

Squamous Cell Carcinoma, SCC, Skin Cancer, Skin metastasis, HNSCC, Carcinoma, Squamous, CMN, Basal cell carcinoma, Superficial sarcoma, Kaposi sarcoma, Alpha radiation, Cutaneous lesion, Tongue cancer, Lip cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

DaRT Seeds

Arm Type

Experimental

Arm Description

Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds

Intervention Type

Device

Intervention Name(s)

Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)

Intervention Description

An intratumoral insertion of a seed(s), loaded with Radium-224, securely fixed in the seeds. The seeds release by recoil into the tumor short-lived alpha-emitting atoms.

Primary Outcome Measure Information:

Title

Tumor response to DaRT

Description

Assessment of the rate of malignant cutaneous, mucosal or superficial soft tissue tumors response using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)

Time Frame

9-11 weeks after DaRT seed insertion.

Title

Adverse Events

Description

The incidence, frequency, severity and causality of acute adverse events related to the DaRT treatment

Time Frame

Time Frame: 9-11 weeks post DaRT insertion.

Secondary Outcome Measure Information:

Title

Assessment of the reduction in tumor volume

Description

Assessment of the reduction in tumor volume based on CT / PET-CT measured tumor volume

Time Frame

9-11 weeks follow-up visit.

Title

DaRT seeds placement.

Description

Assessment of the DaRT seeds placement by localization of the DaRT seeds in the tumor using CT imaging on the day of DaRT insertion.

Time Frame

Day of insertion procedure.

Title

Change in quality of life

Description

Assessment of patient reported health-related Quality of Life outcome after DaRT, using QoL questionnaire Skindex-16 questionnaire score. An overall score ranging from 0 (best) to 100 (worst).

Time Frame

Screening, DaRT removal and day 70 visits.

Title

Change in quality of life

Description

Time Frame

Screening, DaRT removal and day 70 visits.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Subjects with histopathological confirmation of primary or secondary malignant cutaneous neoplastic lesions, or oral cavity mucosal tumors, or superficial soft tissue sarcoma. Subjects with a tumor size ≤ 7 centimeters in the longest diameter. 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. Creatinine ≤1.9 mg/dL. 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 of Keratoacanthoma histology. 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tomer Charas, MD

Organizational Affiliation

Radiotherapy unit at Rambam Health Care Campus, Israel

Official's Role

Principal Investigator

Facility Information:

Facility Name

RAMBAM Health Care Campus

City

Haifa

ZIP/Postal Code

3109601

Country

Israel

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tomer Charas, MD

Phone

+972-4-777-6505

t_charas@rmc.gov.il

First Name & Middle Initial & Last Name & Degree

Tomer Charas, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Alpha Radiation Emitters Device (DaRT) for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia.

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