Alpha Radiation Emitters Device (DaRT) for the Treatment of of Malignant Cutaneous Tumors (NCT04068155) | Clinical Trial Compass
RecruitingNot Applicable
Alpha Radiation Emitters Device (DaRT) for the Treatment of of Malignant Cutaneous Tumors
France80 participantsStarted 2022-04-01
Plain-language summary
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for Malignant Cutaneous Tumors
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
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 newly diagnosed (Cohort A) or locally recurrent (Cohort B) malignant cutaneous lesions of the following histopathologies:
* SCC
* BCC
* Lentigo maligna melanoma (Dubreuilh melanoma)
* Carcinosarcoma
* Acceptable tumor locations include the following:
* Skin (facial, scalp, extremities, torso)
* Lips
* Eyelids
* Subjects with a tumor size ≤ 7 centimeters in the longest diameter.
* Target lesion technically amenable for full tumor coverage with the Alpha DaRT seeds.
* 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 ≥100,000/mm3.
* International normalized ratio of prothrombin time ≤1.8.
* 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 with histology of one of the following:
* Keratoacanthoma
* Merkel cell carcinoma
* Sarcoma other than carcinosarcoma
* Metastatic disease (according to the TNM staging system - M1 patients are excluded)
* 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 us…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.