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Clinical Trials in Israel / NCT05632913
Recruiting Not applicable

Alpha Radiation Emitters Device (DaRT) for the Treatment of Recurrent Lung Cancer

NCT05632913 · tracked via the Priya Life Science Israel tracker
Phase
Not applicable
Started
2023-07-01
Last updated
2026-06-16

Condition(s) studied

Recurrent Lung CancerLung Cancer

Investigational drug(s) / intervention(s)

Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)

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

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hadassah University Hospital Jerusalem Israel Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05632913 on ClinicalTrials.gov ↗ ← All trials in Israel