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Alpha Radiation Emitters Device for the Treatment of of Malignant Cutaneous Tumors

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: NCT04068155
Recruitment Status : Not yet recruiting
First Posted : August 28, 2019
Last Update Posted : July 9, 2020
Sponsor:
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 Malignant Cutaneous Tumors

Condition or disease Intervention/treatment Phase
Skin Cancer Cutaneous Tumor Cutaneous Metastasis Device: DaRT- Diffusing Alpha-emitters Radiation Therapy Not Applicable

Detailed Description:

This will be a prospective, open label, single arm, multi- center study, assessing the safety and effectiveness 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.

Cutaneous lesions with histopathological confirmation of malignancy will be treated using DaRT seeds.

Reduction in tumor size 9-11 weeks following DaRT insertion will be assessed. Safety will be assessed by the frequency, severity and causality of all Adverse Events (AE).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 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 Tumors
Estimated Study Start Date : October 2020
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Skin Cancer

Arm Intervention/treatment
Experimental: DaRT Seeds Intratumoral Diffusing alpha-emitters
An intratumoral insertion of securely fixed seeds loaded with Radium-224. The seeds release by recoil short-lived alpha-emitting atoms into the tumor.
Device: DaRT- Diffusing Alpha-emitters Radiation Therapy
Seed(s) loaded with Radium-224 for local intratumoral irradiation with the destructive power of alpha particles




Primary Outcome Measures :
  1. The objective response rate to DaRT treatment [ Time Frame: up to 9-11 weeks ]
    Assessment of tumor response rate using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)


Secondary Outcome Measures :
  1. Tumor volume [ Time Frame: up to 9-11 weeks ]
    Assessment of the reduction in tumor volume based on imaging tests

  2. DaRT seeds placement [ Time Frame: Day of DaRT insertion procedure ]
    Assessment of the DaRT seed placement by localization of the DaRT seed in the tumor using CT imaging

  3. Change in quality of life as assessed by the Skindex-16 questionnaire [ Time Frame: up to 9-11 weeks ]
    Assessment of patient reported health-related Quality of Life (QoL) outcomes using the Skindex-16 questionnaire

  4. Disease-Free Survival (DFS) rate [ Time Frame: up to 24 months ]
    Assessment of Disease-Free Survival

  5. Change in quality of life as assessed by the Skin Cancer Index (SCI) questionnaire [ Time Frame: up to 9-11 weeks ]
    Assessment of patient reported health-related Quality of Life (QoL) outcomes using the Skin Cancer Index (SCI) questionnaire.


Other Outcome Measures:
  1. Adverse Events [ Time Frame: up to 24 months ]
    Assessment of the frequency, severity and causality of adverse events related and not related to the DaRT treatment. Adverse events will be assessed and graded according to Common Terminology and Criteria for adverse events (CTCAE) version 5.0.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 newly diagnosed (Cohort A) or locally recurrent (Cohort B) malignant cutaneous lesions of the following histopathologies:

    • SCC
    • BCC
    • Lentigo maligna melanoma (Dubreuilh melanoma)
    • Carcinosarcoma
  • Acceptable tumor locations include the following:

    • Skin (facial, scalp, extremities, torso)
    • Lips
    • Eyelids
  • Subjects with a tumor size ≤ 7 centimeters in the longest diameter.
  • Target lesion technically amenable for full tumor coverage with the Alpha DaRT seeds.
  • 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.
  • 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 with histology of one of the following:

    • Keratoacanthoma
    • Merkel cell carcinoma
    • Sarcoma other than carcinosarcoma
  • Metastatic disease (according to the TNM staging system - M1 patients are excluded)
  • 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.

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): NCT04068155


Contacts
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Contact: Naama Barel +972-3-618-24770 Naamab@alphatau.com
Contact: Amnon Gat Amnong@alphatau.com

Sponsors and Collaborators
Alpha Tau Medical LTD.
Investigators
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Principal Investigator: Dr Pascal POMMIER Centre Leon Berard
Principal Investigator: Pr Jean Michel HANNOUN LEVI Antoine Lacassagne Cancer Center
Principal Investigator: Pr Jean Marc COSSET Amethyst (Garenne-Colombes)
Principal Investigator: Dr Pierre BLANCHARD Gustave Roussy, Cancer Campus, Grand Paris
Principal Investigator: Dr Anne DUCASSOU Institut Universitaire du Cancer Toulouse - Oncopole
Principal Investigator: Dr Sophie RENARD Institut de Cancérologie de Lorraine, Nancy
Principal Investigator: Dr Camille VERRY University Hospital, Grenoble
Principal Investigator: Dr Alain TOLEDANO Institut de Cancérologie Hartmann
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Responsible Party: Alpha Tau Medical LTD.
ClinicalTrials.gov Identifier: NCT04068155    
Other Study ID Numbers: CTP-MCT-00
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: July 9, 2020
Last Verified: July 2020
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
Basal Cell Carcinoma
Skin Cancer
Skin Metastasis
Superficial Sarcoma
Alpha Radiation
Cutaneous Lesion
Brachytherapy
Radiotherapy
Lentigo maligna melanoma
Carcinosarcom
scalp cancer
Lip cancer
Eyelid cancer
SCC
Additional relevant MeSH terms:
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Neoplasm Metastasis
Skin Neoplasms
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Skin Diseases