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Alpha Radiation Emitters Device for the Treatment of Recurrent Lung Cancer

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: NCT05632913
Recruitment Status : Recruiting
First Posted : December 1, 2022
Last Update Posted : January 18, 2024
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 treatment of recurrent Lung Cancer .

Condition or disease Intervention/treatment Phase
Recurrent Lung Cancer Lung Cancer Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT) Not Applicable

Detailed Description:

This is a prospective , interventional, open label, single arm, single center study.

The study is designed to evaluate the Feasibility and Safety of DaRT seeds for the treatment of Recurrent Lung Cancer. The study will be comprised of a screening period, DaRT insertion visit, acute follow-up phase of 4- 8 weeks and a long-term follow up phase of 3 months. The total duration of the study will be 3 months from the DaRT insertion procedure.

A total of 10 subjects will be enrolled to the study .

Eligible patients who meet inclusion/exclusion criteria (as assessed during the screening period) will be invited to the site for the procedure of DaRT seeds insertion. The patients will be monitored for a period of 3 months post insertion

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Feasibility and Safety Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Recurrent Lung Cancer
Actual Study Start Date : July 1, 2023
Estimated Primary Completion Date : February 2025
Estimated Study Completion Date : February 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arms and Interventions
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Arm Intervention/treatment
Experimental: DaRT Seeds
Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seed
 Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
An intratumoral insertion of radioactive sources [Ra-224 containing stainless-steel 316LVM tubes- (Alpha DaRT seeds)]. The seeds release by recoil into the tumor short-lived alpha-emitting atoms


Outcome Measures
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Primary Outcome Measures :
  1. Feasibility - DaRT seed placement [ Time Frame: From Day 0-Day 90 ]
    Feasibility will be determined according to the rate of successful placement of DaRT seeds via imaging

  2. Safety- Adverse events [ Time Frame: From Day 0-Day 90 ]
    Safety will be determined according to the overall incidence of device related SAE's graded according to CTCAE v5.0 criteria


Secondary Outcome Measures :
  1. Efficacy - Alpha DaRT seeds [ Time Frame: 1 month and 3 months ]
    Local control evaluation according to RECIST v1.1

  2. Efficacy - Alpha DaRT seeds [ Time Frame: Day 0-Day 90 ]
    Tumor Coverage


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:

  • Histologically and/or cytologically proven recurrent mediastinal tumors
  • Target lesion is technically amenable for at least 50% coverage by the Alpha DaRT seeds as determined by the treating physician
  • Up to two treatable lesions
  • Interstitial radiation indication validated by a multidisciplinary team.
  • Measurable lesion per RECIST (version 1.1) criteria
  • Lesion size ≤ 3 cm in the longest diameter
  • Age ≥18 years old
  • ECOG Performance Status Scale ≤ 3
  • Life expectancy is more than 6 months
  • WBC ≥ 3500/µl, granulocyte ≥ 1500/µl
  • Platelet count ≥60,000/µl
  • Calculated or measured creatinine clearance ≥ 60cc/min. Calculated, or measured creatinine clearance can be≥ 40cc/min given stability of creatinine levels over the past three weeks (at least 1 test per week).
  • AST and ALT ≤ 2.5 X ULN
  • INR < 1.4 for patients not on Warfarin
  • Subjects are willing and able to sign an informed consent form
  • 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.

Exclusion Criteria:

  • Concomitant chemotherapy or immunotherapy
  • Brain metastases Connective tissue disease (scleroderma, lupus)
  • Known hypersensitivity to any of the components of the treatment.
  • Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids.
  • 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.
  • Patient requires treatment not specified in this protocol which may conflict with the endpoints of this study including 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.
  • 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).
  • Breastfeeding women or women of childbearing potential unwilling or unable to use an acceptable contraceptive method to prevent pregnancy for 3 months after RT.
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): NCT05632913


Contacts
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Contact: Liron Dimnik +972237377000 LironD@alphatau.com
Contact: Aviya Hoida +972-2-3737-210 aviyah@alphatau.com

Locations
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Israel
Hadassah University Hospital Recruiting
Jerusalem, Israel, 9777605
Contact: Nevil Berkman, MD         
Contact: ANNIE KEVORKIAN       anniek@hadassah.org.il   
Sponsors and Collaborators
Alpha Tau Medical LTD.
Investigators
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Principal Investigator: Aron Popovtzer, MD Hadassah Medical Organization
More Information
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Responsible Party: Alpha Tau Medical LTD.
ClinicalTrials.gov Identifier: NCT05632913    
Other Study ID Numbers: CTP-LUNG -00
First Posted: December 1, 2022    Key Record Dates
Last Update Posted: January 18, 2024
Last Verified: November 2023
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
Lung cancer
Recurrent lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Recurrence
Disease Attributes
Pathologic Processes
Respiratory Tract Neoplasms
 Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases