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

Overview

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

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2021

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).

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: DaRT Seeds
    • Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • 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).

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Alpha Tau Medical LTD.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Tomer Charas, MD, Principal Investigator, Radiotherapy unit at Rambam Health Care Campus, Israel
  • Overall Contact(s)
    • Naama Barel, +972-3-618-24770, Naamab@alphatau.com

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.