NCT05632913 Alpha Radiation Emitters Device for the Treatment of Recurrent Lung Cancer
| NCT ID | NCT05632913 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Alpha Tau Medical LTD. |
| Condition | Recurrent Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2023-07-01 |
| Primary Completion | 2027-02 |
Trial Parameters
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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 .
Eligibility 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 n
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