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Trial record 2 of 75 for:    Skin Cancer | Jerusalem, Israel
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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.

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 : 56 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 22, 2020
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : January 1, 2025

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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.
Other Name: DaRT


Outcome Measures
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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. Change in tumor volume [ Time Frame: 9-11 weeks post DaRT insertion ]
    Based on imaging

  2. 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

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


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


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. 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.
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): NCT04534127


Contacts
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Contact: Vladislav Rud +972-2-3737-212 vladir@alphatau.com
Contact: Naama Barel +972-2-3737-210 naamab@alphatau.com

Locations
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Israel
Sharett institute, Hadassah Medical Center - Ein-Kerem Recruiting
Jerusalem, Israel, 91120
Contact: Aron Popovtzer, MD         
Sponsors and Collaborators
Alpha Tau Medical LTD.
Investigators
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Principal Investigator: Aron Popovtzer Sharett institute, Hadassah University Hospital - Ein-Kerem
More Information
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Responsible Party: Alpha Tau Medical LTD.
ClinicalTrials.gov Identifier: NCT04534127    
Other Study ID Numbers: CTP-CMN-02_
First Posted: September 1, 2020    Key Record Dates
Last Update Posted: January 13, 2021
Last Verified: January 2021
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.:
Skin Cancer
Skin metastasis
Tongue cancer
Lip cancer
Squamous Cell Carcinoma
SCC
HNSCC
Carcinoma, Squamous
 CMN
Basal cell carcinoma
Superficial sarcoma
Kaposi sarcoma
Alpha radiation
Cutaneous lesion
Brachytherapy
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