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

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ClinicalTrials.gov Identifier: NCT03886181
Recruitment Status : Recruiting
First Posted : March 22, 2019
Last Update Posted : July 25, 2023
Sponsor:
Information provided by (Responsible Party):
Alpha Tau Medical LTD.

Tracking Information
First Submitted Date  ICMJE March 21, 2019
First Posted Date  ICMJE March 22, 2019
Last Update Posted Date July 25, 2023
Actual Study Start Date  ICMJE July 8, 2021
Estimated Primary Completion Date June 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2019)		 Evaluate the safety of the DaRT treatment [ Time Frame: 5-7 weeks after DaRT seed insertion. ]
The study primary objective is to evaluate the safety of the DaRT treatment in terms of incidence of device related Serious Adverse Events (SAE).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 21, 2019)		 Evaluation the effectiveness of the treatment. [ Time Frame: Tumor volume will be measured during screening, 5 and 30-45 days post DaRT after treatment using CT. ]
Evaluation on the effectiveness of the DaRT treatment, in terms of tumor volume reduction.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 21, 2019)		 Evaluate the effectiveness of the DaRT treatment, in terms of percent of necrotic [ Time Frame: 15-30 days after removal of DaRT seeds. ]
Evaluate the effectiveness of the DaRT treatment, in terms of percent of necrotic tissue present in the remaining tumor tissue surgically removed 15-30 days after removal of DaRT seeds.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Alpha Radiation Emitters Device for the Treatment of Cutaneous, Mucosal and Superficial Soft Tissue Neoplasia (DaRT)
Official Title  ICMJE A Safety and Preliminary Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters on Cutaneous, Mucosal and 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 volume and evaluation the percent of necrotic tissue in the tumor 30-45 days after DaRT seeds insertion (15-30 days after seed removal) will be assessed. Safety will be assessed by the cumulative incidence, worst severity and frequency of adverse events (AEs) observed including the follow-up period.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Skin Cancer
  • Mucosal Neoplasm of Oral Cavity
  • Soft Tissue Neoplasm
Intervention  ICMJE Device: 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  ICMJE Experimental: DaRT Seeds
Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds
Intervention: Device: Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 21, 2019)		 35
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2024
Estimated Primary Completion Date June 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects with histopathological confirmation of cutaneous and/or mucosal and/or superficial soft tissue malignant neoplasia.
  • Subjects with a tumor size ≤ 5 centimeters in the longest diameter.
  • Subjects' age is over 18 years old.
  • Subjects' ECOG Performance Status Scale is < 2.
  • Subjects' life expectancy is more than 6 months.
  • Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test.
  • Subjects are able and willing to sign an informed consent form.

Exclusion Criteria:

  • Subject has a tumor with a maximal diameter > 5 centimeters.
  • Subjects' ECOG Performance Status Scale is > 3.
  • Subject has a tumor of Keratoacanthoma histology.
  • Patients with moribund diseases, e.g., autoimmune diseases, vasculitis, etc.
  • Patients under systemic immunosuppressive and/or corticosteroid treatment. Patients taking corticosteroid inhalers are eligible.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Liron Dimnik +972-2-373-7000 LironD@alphatau.com
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03886181
Other Study ID Numbers  ICMJE CTP-CMN-01
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  ICMJE
Plan to Share IPD: No
Current Responsible Party Alpha Tau Medical LTD.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Alpha Tau Medical LTD.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Laura Eibenschuz, MD IFO S. Gallicano
PRS Account Alpha Tau Medical LTD.
Verification Date June 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP