Alpha Radiation Emitters Device for the Treatment of Recurrent Lung Cancer

A Feasibility and Safety Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Recurrent Lung Cancer

A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for treatment of recurrent Lung Cancer .

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer; Recurrent Lung Cancer
• Intervention / Treatment: Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)

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 Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Liron Dimnik; Phone Number: +972237377000; Email: LironD@alphatau.com
• Study Contact Backup: Name: Aviya Hoida; Phone Number: +972-2-3737-210; Email: aviyah@alphatau.com

Study Locations

• Israel
  • Jerusalem, Israel, 9777605
    • Recruiting
    • Hadassah University Hospital
    • Contact: Nevil Berkman, MD
    • Contact: ANNIE KEVORKIAN; Email: anniek@hadassah.org.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility - DaRT seed placement	Feasibility will be determined according to the rate of successful placement of DaRT seeds via imaging	From Day 0-Day 90
Safety- Adverse events	Safety will be determined according to the overall incidence of device related SAE's graded according to CTCAE v5.0 criteria	From Day 0-Day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy - Alpha DaRT seeds	Local control evaluation according to RECIST v1.1	1 month and 3 months
Efficacy - Alpha DaRT seeds	Tumor Coverage	Day 0-Day 90

Collaborators and Investigators

• Sponsor: Alpha Tau Medical LTD.
• Investigators: Principal Investigator: Aron Popovtzer, MD, Hadassah Medical Organization

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2023
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: November 21, 2022
• First Submitted That Met QC Criteria: November 21, 2022
• First Posted (Actual): December 1, 2022

Study Record Updates

• Last Update Posted (Actual): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 17, 2024
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Lung cancer; Alpha radiation; Recurrent lung cancer
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Disease Attributes; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Recurrence
• Other Study ID Numbers: CTP-LUNG -00

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No