Alpha Radiation Emitters Device for the Treatment of Recurrent Lung Cancer

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05632913
• Other study ID #: CTP-LUNG -00
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2023
• Est. completion date: February 2027

Study information

• Verified date: November 2023
• Source: Alpha Tau Medical LTD.
• Contact: Liron Dimnik
• Phone: +972237377000
• Email: LironD[@]alphatau.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: February 2027
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Recurrence
• Recurrent Lung Cancer

Intervention

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

Locations

Country	Name	City	State
Israel	Hadassah University Hospital	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Alpha Tau Medical LTD.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Efficacy - Alpha DaRT seeds	Local control evaluation according to RECIST v1.1	1 month and 3 months
Secondary	Efficacy - Alpha DaRT seeds	Tumor Coverage	Day 0-Day 90