Alpha Radiation Emitters Device (DaRT) for Target Treatments of Malignant Tumors
ConditionMalignant Tumor
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlpha Tau Medical LTD.
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Experimental: DaRT seeds
DeviceDaRT source will be inserted using preplanned radiotherapy parameters and reassessed by volumetric imaging 2-3 weeks after placement and then removed. The study objectives are to collect data on the general safety and efficacy of DaRT among patients who do not fit the entry criteria of existing investigational trials.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: DaRT seedsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
To assess the frequency, severity and causality of acute adverse events.
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.
Time frame
From Day 0 (DaRT insertion )Secondary outcomes
1
To assess the tumor response to DaRT treatment
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)
Time frame
3 months after DaRT seed insertionSponsors and contacts
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Source ClinicalTrials.gov