๐ฌIn plain words
What the trial is, and whether it could suit you
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for superficial cutaneous, mucosal or soft tissue neoplasia
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* 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 โค 7 centimeters in the longest diameter.
* Measurable disease according to RECIST v1.1.
* Subjects over 18 years old.
* Subjects' ECOG Performance Status Scale is \< 2.
* Subjects' life expectancy is more than 6 months.
* Platelet count โฅ100,000/mm3.
* International normalized ratio of prothrombin time โค1.8.
* Creatinine โค1.9 mg/dL.
* Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test.
* Subjects are willing to sign an informed consent form.
Exclusion Criteria:
* 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.
* High probability of protocol non-compliance (in opinion of investigator).
* Subjects not willing to sign an informed consent.
* Women who are pregnant or breastfeeding.
๐
What it tests
- Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
RAMBAM Health Care Campus
Haifa, Israel
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.