Actively Recruiting
A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters for Malignant Cutaneous Tumors
Led by Alpha Tau Medical LTD. · Updated on 2024-11-22
80
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new treatment approach for malignant cutaneous tumors using intratumoral diffusing alpha radiation emitters (DaRT). This prospective, open-label, single-arm, multi-center study aims to assess the safety and effectiveness of DaRT, which delivers alpha radiation through radioactive seeds inserted directly into tumors. The study focuses on tumors confirmed to be malignant through histopathology, with a goal of reducing tumor size within 9 to 11 weeks after treatment. The treatment involves inserting securely fixed seeds loaded with Radium-224 into the tumor. These seeds release short-lived alpha-emitting atoms locally within the tumor, combining the benefits of traditional brachytherapy with the potent effects of alpha radiation at lower doses than conventional radiation therapy. This single treatment period is followed by monitoring and assessments to evaluate outcomes. Participants will be monitored for tumor response, safety, and quality of life over several weeks. The primary measure is the objective response rate within 9 to 11 weeks after DaRT insertion. Additional assessments include tumor volume changes, seed placement on the day of the procedure, quality of life questionnaires, and disease-free survival up to 24 months. Safety is evaluated by tracking adverse events, and participants' performance status and life expectancy are also considered throughout the study.
CONDITIONS
Brief Title
Alpha Radiation Emitters Device for the Treatment of of Malignant Cutaneous Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects with histopathological confirmation of newly diagnosed or locally recurrent malignant cutaneous lesions including SCC, BCC, lentigo maligna melanoma, or carcinosarcoma
- Tumor locations include skin (facial, scalp, extremities, torso), lips, or eyelids
- Tumor size 7 centimeters or smaller in longest diameter
- Tumor amenable for full coverage with DaRT seeds
- Measurable disease according to RECIST v1.1
- Age 18 years or older
- ECOG Performance Status less than 2
- Life expectancy more than 6 months
- Platelet count at least 100,000/mm3
- INR of prothrombin time 1.8 or less
- Women of childbearing potential must have negative pregnancy test
- Willingness to sign informed consent form
You will not qualify if you...
- Tumor histology of keratoacanthoma, Merkel cell carcinoma, or sarcoma other than carcinosarcoma
- Presence of metastatic disease (M1 patients excluded)
- Significant comorbidities conflicting with study endpoints
- Systemic immunosuppressive therapy except brief corticosteroid use
- Participation in another interventional study within past 30 days
- High probability of protocol non-compliance
- Unwillingness to sign informed consent
- Pregnant or breastfeeding women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of DaRT insertion procedure
Participants receive an intratumoral insertion of DaRT seeds loaded with Radium-224 for local alpha radiation therapy targeting malignant cutaneous tumors.
1 visit (in-person)
Duration - Up to 9 to 11 weeks
Participants are monitored for tumor response and safety, including assessments of tumor size, quality of life, and adverse events.
Multiple visits for assessments up to 11 weeks
Duration - Up to 24 months
Participants are followed for disease-free survival and long-term safety outcomes.
Periodic follow-up visits up to 24 months
Trial Site Locations
Total: 2 locations
1
CHU Grenoble Alpes
Grenoble, France, 38700
Actively Recruiting
2
Centre Léon Bérard
Lyon, France, 69008
Actively Recruiting
Research Team
L
Liron Dimnik
A
Amnon Gat
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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