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Clinical Trials in France / NCT04068155
Recruiting Not applicable

Alpha Radiation Emitters Device (DaRT) for the Treatment of of Malignant Cutaneous Tumors

NCT04068155 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2022-04-01
Last updated
2026-06-16

Condition(s) studied

Skin CancerCutaneous TumorCutaneous Metastasis

Investigational drug(s) / intervention(s)

DaRT- Diffusing Alpha-emitters Radiation Therapy

DaRT- Diffusing Alpha-emitters Radiation Therapy: Seed(s) loaded with Radium-224 for local intratumoral irradiation with the destructive power of alpha particles

Study summary

A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for Malignant Cutaneous Tumors

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
CHU Grenoble Alpes Grenoble France Recruiting
Centre Léon Bérard Lyon France Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04068155 on ClinicalTrials.gov ↗ ← All trials in France