Alpha Radiation Emitters Device (DaRT) for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAlpha Tau Medical LTD.
About this trial
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for superficial cutaneous, mucosal or soft tissue neoplasia
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects with histopathological confirmation of primary or secondary malignant cutaneous neoplastic lesions, or oral cavity mucosal tumors, or superficial soft tissue sarcoma. Confirmation obtained within 6 months of planned treatment.
Subjects with a tumor size ≤ 7 centimeters in the longest diameter.
Targetable lesion must be technically amenable for complete coverage (including margins) by the DaRT seeds
Brachytherapy indication validated by a multidisciplinary team
Disqualifiers
Subject has a tumor of Keratoacanthoma histology.
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.
Trial design
Design model
Single group
Treatments tested in this trial
Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
DeviceAn intratumoral insertion of a seed(s), loaded with Radium-224, securely fixed in the seeds. The seeds release by recoil into the tumor short-lived alpha-emitting atoms.
Treatment groups
56 Participants
are divided into 1 treatment groupGroup A: DaRT SeedsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Tumor response to DaRT
Assessed using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)
Time frame
9-11 weeks post DaRT insertion2
Adverse Events
The incidence, frequency, severity and causality of acute adverse events related to the DaRT treatment according to Common Terminology and Criteria for adverse events (CTCAE) version 5.0.
Time frame
Up to 24 MonthsSecondary outcomes
1
Change in tumor volume
Based on imaging
Time frame
9-11 weeks post DaRT insertion2
DaRT seeds placement
Assessment by localization of the DaRT seeds in the tumor using CT imaging on the day of DaRT insertion
Time frame
1 Day of procedure3
Change in quality of life
Assessment of patient reported health-related Quality of Life outcome after DaRT, using QoL questionnaire Skindex-16 questionnaire score
Time frame
Day 15, Day 30, Day 70, Day 180 post DaRT insertion4
Change in quality of life
Assessment of patient reported health-related Quality of Life outcome after DaRT, using QoL questionnaire Skin Cancer Index (SCI) questionnaire score
Time frame
Day 30, Day 70, Day 180 post DaRT insertionOther outcomes
1
Adverse Events
All Adverse Events (AE) related and unrelated to the study treatment
Time frame
Up to 24 MonthsSponsors and contacts
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Source ClinicalTrials.gov