Actively Recruiting
Alpha Radiation Emitters Device for the Treatment of of Malignant Cutaneous Tumors
Led by Alpha Tau Medical LTD. · Updated on 2024-11-22
80
Participants Needed
2
Research Sites
143 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for Malignant Cutaneous Tumors
CONDITIONS
Official 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
- Tumors located on the skin (facial, scalp, extremities, torso), lips, or eyelids
- Tumor size of 7 centimeters or less in longest diameter
- Target lesion amenable for full coverage with Alpha DaRT seeds
- Measurable disease according to RECIST v1.1
- Aged 18 years or older
- ECOG Performance Status less than 2
- Life expectancy greater than 6 months
- Platelet count of at least 100,000/mm3
- International normalized ratio of prothrombin time less than or equal to 1.8
- Women of childbearing potential with negative pregnancy test
- Willingness to sign informed consent form
You will not qualify if you...
- Tumors with histology of keratoacanthoma, Merkel cell carcinoma, or sarcoma other than carcinosarcoma
- Presence of metastatic disease (M1 patients excluded)
- Significant comorbidities that may interfere with study endpoints
- Undergoing systemic immunosuppressive therapy except brief intermittent corticosteroids
- Participation in another interventional study within past 30 days that may conflict with this study
- 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
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
CONTACT
A
Amnon Gat
CONTACT
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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