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Retreatment With Intratumoral Diffusing Alpha Radiation Emitters

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. Identifier: NCT04540588
Recruitment Status : Recruiting
First Posted : September 7, 2020
Last Update Posted : January 14, 2021
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 re-treatment with 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 either recurrent or persistent disease following DaRT treatment. .

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 : 39 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Safety and Efficacy Study of Retreatment With Intratumoral Diffusing Alpha Radiation Emitters
Actual Study Start Date : December 22, 2020
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : January 1, 2024

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: From conscent up to 9-11 weeks post DaRT insertion ]
    Frequency, severity and causality of acute adverse events 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.

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

  2. Local control rate [ Time Frame: 9-11 weeks post DaRT insertion ]
    Will be assessed as the number of complete responses, partial responses and stable disease divided by the total numbers of tumors treated.

Other Outcome Measures:
  1. Adverse Events [ Time Frame: From conscent up to 9-11 weeks post DaRT insertion ]
    Incidence of all Adverse Events (AE) related and unrelated to the study treatment.

Information from the National Library of Medicine

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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 either recurrent or persistent disease following DaRT treatment.
  • Subjects with a tumor size ≤ 5 centimeters in the longest diameter.
  • Target lesion technically amenable for full coverage with the Alpha DaRT seeds.
  • Brachytherapy indication validated by a multidisciplinary team.
  • 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.
  • AST and ALT ≤ 2.5 X ULN
  • WBC ≥ 3500/μl, granulocyte ≥ 1500/μl
  • International normalized ratio of prothrombin time ≤1.4 for patients not on Warfarin
  • Creatinine ≤2.3 mg/dL.
  • Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test before the Ra-224 implantation 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:

  • Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids
  • 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.
  • Patients with uncontrolled intercurrent illnesses including, but not limited to an active infection requiring systemic therapy or a known psychiatric or substance abuse disorder(s) that would interfere with cooperation with the requirements of the trial or interfere with the study endpoints.
  • Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
  • 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.
  • 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 identifier (NCT number): NCT04540588

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Contact: Adi Cohen +972-2-3737-212
Contact: Naama Barel +972-2-3737-210

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Sharett institute, Hadassah University Hospital - Ein-Kerem Recruiting
Jerusalem, Israel, 91120
Contact: Aron Popovtzer, MD         
Sponsors and Collaborators
Alpha Tau Medical LTD.
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Principal Investigator: Aron Popovtzer, M.D Sharett institute, Hadassah Medical Center - Ein-Kerem
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Responsible Party: Alpha Tau Medical LTD. Identifier: NCT04540588    
Other Study ID Numbers: CTP-CMN-05
First Posted: September 7, 2020    Key Record Dates
Last Update Posted: January 14, 2021
Last Verified: January 2021

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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
Skin Cancer
Skin metastasis
Carcinoma, Squamous
Basal cell carcinoma
Superficial sarcoma
Kaposi sarcoma
Alpha radiation
Cutaneous lesion
Tongue cancer
Lip cancer
Recurrent disease
Persistent lesion
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