Alpha Radiation Emitters Device for the Treatment of Cutaneous, Mucosal and Superficial Soft Tiss… (NCT03886181) | Clinical Trial Compass
TerminatedNot Applicable
Alpha Radiation Emitters Device for the Treatment of Cutaneous, Mucosal and Superficial Soft Tissue Neoplasia (DaRT)
Stopped: Difficulties in recruitment and the site's resources to recruit patients
Italy2 participantsStarted 2021-07-08
Plain-language summary
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for superficial cutaneous, mucosal or soft tissue neoplasia
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subjects with histopathological confirmation of cutaneous and/or mucosal and/or superficial soft tissue malignant neoplasia.
* Subjects with a tumor size ≤ 5 centimeters in the longest diameter.
* Subjects' age is over 18 years old.
* Subjects' ECOG Performance Status Scale is \< 2.
* Subjects' life expectancy is more than 6 months.
* Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test.
* Subjects are able and willing to sign an informed consent form.
Exclusion Criteria:
* Subject has a tumor with a maximal diameter \> 5 centimeters.
* Subjects' ECOG Performance Status Scale is \> 3.
* Subject has a tumor of Keratoacanthoma histology.
* Patients with moribund diseases, e.g., autoimmune diseases, vasculitis, etc.
* Patients under systemic immunosuppressive and/or corticosteroid treatment. Patients taking corticosteroid inhalers are eligible.