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

• ClinicalTrials.gov Identifier: NCT03889899
• Recruitment Status: Recruiting
• First Posted: March 26, 2019
• Last Update Posted: July 25, 2023
• Sponsor: Alpha Tau Medical LTD.
• Information provided by (Responsible Party): Alpha Tau Medical LTD.

Tracking Information

• First Submitted Date: March 21, 2019
• First Posted Date: March 26, 2019
• Last Update Posted Date: July 25, 2023
• Actual Study Start Date: October 21, 2020
• Estimated Primary Completion Date: June 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 25, 2019)

• Tumor response to DaRT [ Time Frame: 9-11 weeks after DaRT seed insertion. ]
  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 [ Time Frame: Time Frame: 9-11 weeks post DaRT insertion. ]
  The incidence, frequency, severity and causality of acute adverse events related to the DaRT treatment

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: June 2, 2019)

• Assessment of the reduction in tumor volume [ Time Frame: 9-11 weeks follow-up visit. ]
  Assessment of the reduction in tumor volume based on CT / PET-CT measured tumor volume
• DaRT seeds placement. [ Time Frame: Day of insertion procedure. ]
  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 [ Time Frame: Screening, DaRT removal and day 70 visits. ]
  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 [ Time Frame: Screening, DaRT removal and day 70 visits. ]
  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).

Original Secondary Outcome Measures (submitted: March 25, 2019)

• Assessment of the reduction in tumor volume [ Time Frame: 9-11 weeks follow-up visit. ]
  Assessment of the reduction in tumor volume based on CT / PET-CT measured tumor volume
• DaRT seeds placement. [ Time Frame: Day of insertion procedure. ]
  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 [ Time Frame: Screening, DaRT removal and day 70 visits. ]
  Assessment of patient reported health-related Quality of Life outcome after DaRT, using QoL questionnaire Skindex-16 questionnaire score
• Change in quality of life [ Time Frame: Screening, DaRT removal and day 70 visits. ]
  Assessment of patient reported health-related Quality of Life outcome after DaRT, using QoL questionnaire Skin Cancer Index (SCI) questionnaire score

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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).

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

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

Intervention

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.

Study Arms

Experimental: DaRT Seeds

Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds

Intervention: Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: March 25, 2019): 30
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 2024
• Estimated Primary Completion Date: June 2024 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Liron Dimnik; +972-2-373-7000; LironD@alphatau.com

• Listed Location Countries: Israel

Administrative Information

• NCT Number: NCT03889899
• Other Study ID Numbers: CTP-CMN-03
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Alpha Tau Medical LTD.
• Original Responsible Party: Same as current
• Current Study Sponsor: Alpha Tau Medical LTD.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Tomer Charas, MD; Radiotherapy unit at Rambam Health Care Campus, Israel

• PRS Account: Alpha Tau Medical LTD.
• Verification Date: July 2023