Clinical trial · Interventional
Alpha Radiation Emitters Device (DaRT) for the Treatment of of Malignant Cutaneous Tumors
A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Malignant Cutaneous Tumors
NCT04068155CI-TRIAL-00114949recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for Malignant Cutaneous Tumors
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cutaneous Metastasis | — | UNRESOLVED | — |
| Cutaneous Tumor | — | UNRESOLVED | — |
| Skin Cancer | Malignant Skin Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DaRT- Diffusing Alpha-emitters Radiation Therapy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DaRT Seeds Intratumoral Diffusing alpha-emitters
- description
- An intratumoral insertion of securely fixed seeds loaded with Radium-224. The seeds release by recoil short-lived alpha-emitting atoms into the tumor.
- interventionNames
- Device: DaRT- Diffusing Alpha-emitters Radiation Therapy
Primary outcomes (1)
- measure
- The objective response rate to DaRT treatment
- timeFrame
- up to 9-11 weeks
- description
- Assessment of tumor response rate using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)
Secondary outcomes (5)
- measure
- Tumor volume
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.