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

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

A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for superficial cutaneous, mucosal or soft tissue neoplasia

Study Overview

• Status: Recruiting
• Conditions: Skin Cancer; Mucosal Neoplasm of Oral Cavity; Soft Tissue Neoplasm
• Intervention / Treatment: Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)

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).

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

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

Study Locations

• Israel
  • Haifa, Israel, 3109601
    • Recruiting
    • Rambam Health Care Campus
    • Contact: Tomer Charas, MD; Phone Number: +972-4-777-6505; Email: t_charas@rmc.gov.il
    • Principal Investigator: Tomer Charas, MD

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 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.

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 Radiation Therapy (DaRT) Seeds	Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	9-11 weeks after DaRT seed insertion.
Adverse Events	The incidence, frequency, severity and causality of acute adverse events related to the DaRT treatment	Time Frame: 9-11 weeks post DaRT insertion.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of the reduction in tumor volume	Assessment of the reduction in tumor volume based on CT / PET-CT measured tumor volume	9-11 weeks follow-up visit.
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.	Day of insertion procedure.
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).	Screening, DaRT removal and day 70 visits.
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).	Screening, DaRT removal and day 70 visits.

Collaborators and Investigators

• Sponsor: Alpha Tau Medical LTD.
• Investigators: Principal Investigator: Tomer Charas, MD, Radiotherapy unit at Rambam Health Care Campus, Israel

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2020
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: March 21, 2019
• First Submitted That Met QC Criteria: March 25, 2019
• First Posted (Actual): March 26, 2019

Study Record Updates

• Last Update Posted (Actual): July 25, 2023
• Last Update Submitted That Met QC Criteria: July 23, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Skin Cancer; HNSCC; Squamous Cell Carcinoma; SCC; Alpha radiation; Basal cell carcinoma; Skin metastasis; Carcinoma, Squamous; CMN; Superficial sarcoma; Kaposi sarcoma; Cutaneous lesion; Tongue cancer; Lip cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Site; Head and Neck Neoplasms; Stomatognathic Diseases; Mouth Diseases; Neoplasms; Skin Neoplasms; Mouth Neoplasms; Soft Tissue Neoplasms
• Other Study ID Numbers: CTP-CMN-03

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