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.
Subjects with a tumor size ≤ 7 centimeters in the longest diameter.
Measurable disease according to RECIST v1.1.
Subjects over 18 years old.
Disqualifiers
Subject has a tumor of Keratoacanthoma histology.
Patients with significant comorbidities that the treating physician deems may conflict with the endpoints of the study (e.g., poorly controlled autoimmune diseases, vasculitis, etc.)
Patients undergoing systemic immunosuppressive therapy excepting intermittent, brief use of systemic corticosteroids
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
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
30 Participants
are divided into 1 treatment groupGroup A: DaRT SeedsExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Tumor response to DaRT
Assessment of the rate of malignant cutaneous, mucosal or superficial soft tissue tumors response using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)
Time frame
9-11 weeks after DaRT seed insertion.2
Adverse Events
The incidence, frequency, severity and causality of acute adverse events related to the DaRT treatment
Time frame
Time Frame: 9-11 weeks post DaRT insertion.Secondary outcomes
1
Assessment of the reduction in tumor volume
Assessment of the reduction in tumor volume based on CT / PET-CT measured tumor volume
Time frame
9-11 weeks follow-up visit.2
DaRT seeds placement.
Assessment of the DaRT seeds placement by localization of the DaRT seeds in the tumor using CT imaging on the day of DaRT insertion.
Time frame
Day of insertion procedure.3
Change in quality of life
Assessment of patient reported health-related Quality of Life outcome after DaRT, using QoL questionnaire Skindex-16 questionnaire score. An overall score ranging from 0 (best) to 100 (worst).
Time frame
Screening, DaRT removal and day 70 visits.4
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. An overall score ranging from 0 (best) to 100 (worst).
Time frame
Screening, DaRT removal and day 70 visits.Sponsors and contacts
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Source ClinicalTrials.gov