New radiation implant shows promise for skin cancer
NCT ID NCT04068155
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new device that delivers a special type of radiation directly into skin tumors. The goal is to see if it can shrink or control the cancer. The study is for adults with certain types of skin cancer, including squamous cell carcinoma and basal cell carcinoma. Participants will receive the treatment and be monitored for tumor response and side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 80 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2022
- Expected to finish
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Jan 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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CHU Grenoble Alpes
RECRUITINGGrenoble, 38700, France
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Centre Léon Bérard
RECRUITINGLyon, 69008, France
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