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Trial record 2 of 77 for:    Skin Cancer | Jerusalem, Israel

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

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ClinicalTrials.gov Identifier: NCT04534127
Recruitment Status : Recruiting
First Posted : September 1, 2020
Last Update Posted : January 13, 2021
Sponsor:
Information provided by (Responsible Party):
Alpha Tau Medical LTD.

Tracking Information
First Submitted Date  ICMJE August 18, 2020
First Posted Date  ICMJE September 1, 2020
Last Update Posted Date January 13, 2021
Actual Study Start Date  ICMJE December 22, 2020
Estimated Primary Completion Date January 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2020)
  • 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)
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2020)
  • Change in tumor volume [ Time Frame: 9-11 weeks post DaRT insertion ]
    Based on imaging
  • DaRT seeds placement [ Time Frame: 1 Day of procedure ]
    Assessment 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: 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
  • 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
  • Progression Free Survival [ Time Frame: 24 months post DaRT insertion ]
    Time elapsed from response to disease progression
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 30, 2020)
Adverse Events [ Time Frame: Up to 24 Months ]
All Adverse Events (AE) related and unrelated to the study treatment
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Alpha Radiation Emitters Device (DaRT) for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia
Official Title  ICMJE 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  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: 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
Study Arms  ICMJE Experimental: DaRT Seeds
Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds
Intervention: 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: August 30, 2020)
56
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2025
Estimated Primary Completion Date January 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subjects with histopathological confirmation of primary or secondary malignant cutaneous neoplastic lesions, or oral cavity mucosal tumors, or superficial soft tissue sarcoma. Confirmation obtained within 6 months of planned treatment.
  • Subjects with a tumor size ≤ 7 centimeters in the longest diameter.
  • Targetable lesion must be technically amenable for complete coverage (including margins) by the DaRT seeds
  • Brachytherapy indication validated by a multidisciplinary team
  • 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.
  • 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.
  • WBC ≥ 3500/μl, granulocyte ≥ 1500/μl
  • AST and ALT ≤ 2.5 X ULN
  • 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 and are required to use an acceptable contraceptive method to prevent pregnancy for 3 months after brachytherapy.
  • Subjects are willing to sign an informed consent form.

Exclusion Criteria:

  • Subject has a tumor of Keratoacanthoma histology.
  • Known hypersensitivity to any of the components of the treatment.
  • Clinically significant cardiovascular disease, e.g. cardiac failure of New York Heart Association classes III-IV, uncontrolled coronary artery disease, cardiomyopathy, uncontrolled arrhythmia, uncontrolled hypertension, or history of myocardial infarction in the last 12 months.
  • Any medical or psychiatric illness which in the opinion of the investigator would compromise the patient's ability to tolerate this treatment or interfere with the study endpoints.
  • Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids
  • Patient requires treatment which may conflict with the endpoints of this study including evaluation of response or toxicity of DaRT
  • 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.
  • Patients must agree to use adequate contraception (vasectomy or barrier method of birth control) prior to study entry, for the duration of study participation and for 3 months after discontinuing therapy.
  • 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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Vladislav Rud +972-2-3737-212 vladir@alphatau.com
Contact: Naama Barel +972-2-3737-210 naamab@alphatau.com
Listed Location Countries  ICMJE Israel
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04534127
Other Study ID Numbers  ICMJE CTP-CMN-02_
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
Responsible Party Alpha Tau Medical LTD.
Study Sponsor  ICMJE Alpha Tau Medical LTD.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Aron Popovtzer Sharett institute, Hadassah University Hospital - Ein-Kerem
PRS Account Alpha Tau Medical LTD.
Verification Date January 2021

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