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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03889899
Recruitment Status : Recruiting
First Posted : March 26, 2019
Last Update Posted : July 25, 2023
Sponsor:
Information provided by (Responsible Party):
Alpha Tau Medical LTD.

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

Condition or disease Intervention/treatment Phase
Skin Cancer Mucosal Neoplasm of Oral Cavity Soft Tissue Neoplasm Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT) Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 21, 2020
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : September 2024

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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)

  2. 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 Outcome Measures :
  1. 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

  2. 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.

  3. 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).

  4. 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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03889899


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

Locations
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Israel
RAMBAM Health Care Campus Recruiting
Haifa, Israel, 3109601
Contact: Tomer Charas, MD    +972-4-777-6505    t_charas@rmc.gov.il   
Principal Investigator: Tomer Charas, MD         
Sponsors and Collaborators
Alpha Tau Medical LTD.
Investigators
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Principal Investigator: Tomer Charas, MD Radiotherapy unit at Rambam Health Care Campus, Israel
More Information
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Responsible Party: Alpha Tau Medical LTD.
ClinicalTrials.gov Identifier: NCT03889899    
Other Study ID Numbers: CTP-CMN-03
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: July 25, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alpha Tau Medical LTD.:
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
Additional relevant MeSH terms:
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Neoplasms
Skin Neoplasms
Soft Tissue Neoplasms
Mouth Neoplasms
Neoplasms by Site
 Skin Diseases
Head and Neck Neoplasms
Mouth Diseases
Stomatognathic Diseases