NCT05781555 Alpha Radiation Emitters Device (DaRT) for Target Treatments of Malignant Tumors
| NCT ID | NCT05781555 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Alpha Tau Medical LTD. |
| Condition | Malignant Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-03-22 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2023-03-22 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study is a Compassionate clinical study for the treatment of Malignant Tumors. The primary endpoint of the study is to assess the frequency, severity and causality of acute adverse events related to the DaRT treatment. Adverse events will be assessed and graded according to Common Terminology and Criteria for Adverse Events (CTCAE) version 5.0. The secondary endpoint is to assess the tumor response to DaRT treatment assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1) 3 months after DaRT seed insertion.
Eligibility Criteria
Inclusion Criteria: * Subjects with any malignancy * Subjects with a tumor size ≤ 7 centimeters in the longest diameter * Subjects over 18 years old * Subjects' life expectancy is more than 6 months * Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test and are required to use an acceptable contraceptive method to prevent pregnancy for 3 months after treatment. * Subjects/Surrogate decision maker are willing to sign an informed consent form Exclusion Criteria: * Known hypersensitivity to any of the components of the treatment. * 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. * Any medical or psychiatric illness which in the opinion of the investigator would compromise the patient's ability to tolerate this treatment or interfere with the study endpoints. * 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. * 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. * High probability of protocol non-compliance (in opinion of investigator). * Subjects/Surrogate decision maker not willing to sign an informed consent. * Women who are pregnant or breastfeeding.
Contact & Investigator
Aron Popovzer, MD
PRINCIPAL INVESTIGATOR
Hadassah University Hospital - Ein Kerem
Frequently Asked Questions
Who can join the NCT05781555 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Malignant Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05781555 currently recruiting?
Yes, NCT05781555 is actively recruiting participants. Contact the research team at LironD@alphatau.com for enrollment information.
Where is the NCT05781555 trial being conducted?
This trial is being conducted at Jerusalem, Israel.
Who is sponsoring the NCT05781555 clinical trial?
NCT05781555 is sponsored by Alpha Tau Medical LTD.. The principal investigator is Aron Popovzer, MD at Hadassah University Hospital - Ein Kerem. The trial plans to enroll 100 participants.