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

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ClinicalTrials.gov Identifier: NCT03737734
Recruitment Status : Recruiting
First Posted : November 9, 2018
Last Update Posted : June 15, 2022
Information provided by (Responsible Party):
Alpha Tau Medical LTD.

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).

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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 : December 31, 2018
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2025

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.
Other Name: DaRT

Primary Outcome Measures :
  1. Tumor response to DaRT [ Time Frame: 9-11 weeks post DaRT insertion ]
    Assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)

  2. Adverse Events [ Time Frame: Up to 24 Months ]
    The incidence, frequency, severity and causality of acute adverse events related to the DaRT treatment according to Common Terminology and Criteria for adverse events (CTCAE) version 5.0.

Secondary Outcome Measures :
  1. Reduction in tumor volume [ Time Frame: 9-11 weeks post DaRT insertion ]
    based on imaging

  2. DaRT seeds placement [ Time Frame: Day of insertion procedure ]
    Assessment 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: Day 15, Day 30, Day 70, Day 180 post DaRT insertion ]
    Assessment of patient reported health-related Quality of Life outcome after DaRT, using QoL questionnaire Skindex-16 questionnaire score

  4. Change in quality of life [ Time Frame: Day 30, Day 70, Day 180 post DaRT insertion ]
    Assessment of patient reported health-related Quality of Life outcome after DaRT, using QoL questionnaire Skin Cancer Index (SCI) questionnaire score

  5. Adverse Events [ Time Frame: Up to 24 Months ]
    All Adverse Events (AE) related and unrelated to the study treatment

  6. Progression Free Survival [ Time Frame: 24 months post DaRT insertion ]
    Time elapsed from response to disease progression

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  • Patients who have either failed first-line treatment, or are medically unfit for standard of care (surgery, external-beam radiation therapy or chemotherapy), or refuse standard of care.
  • 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)
  • Women who are pregnant or breastfeeding.

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): NCT03737734

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Contact: Liron Dimnik +972-2-3737-7000 LironD@alphatau.com

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Davidof Cancer Institution at the Rabin Medical Center Israel Recruiting
Petah tikva, Israel, 49100
Contact: Noga Korman, MD    +972-526630974    NogaKu1@clalit.org.il   
Sponsors and Collaborators
Alpha Tau Medical LTD.
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Principal Investigator: Noga Kurman, MD Davidof Cancer Institution at Rabin Medical Center Israel
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Responsible Party: Alpha Tau Medical LTD.
ClinicalTrials.gov Identifier: NCT03737734    
Other Study ID Numbers: CTP-CMN-02
First Posted: November 9, 2018    Key Record Dates
Last Update Posted: June 15, 2022
Last Verified: April 2022
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.:
Alpha radiation
Squamous Cell Carcinoma
Skin Cancer
Skin metastasis
Carcinoma, Squamous
Basal cell carcinoma
Superficial sarcoma
Kaposi sarcoma
Cutaneous lesion
Tongue cancer
Lip cancer
Additional relevant MeSH terms:
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Skin Neoplasms
Soft Tissue Neoplasms
Mouth Neoplasms
Neoplasms by Site
Skin Diseases
Head and Neck Neoplasms
Mouth Diseases
Stomatognathic Diseases