Clinical trial · Interventional
Alpha Radiation Emitters Device for the Treatment of Squamous Cell Carcinoma (DaRT)
A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters on Squamous Cell Carcinoma
NCT03353077CI-TRIAL-00050585completedN/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 Skin Squamous Cell Carcinoma (SCC) treatment employing intratumoral diffusing alpha radiation emitter device
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Skin Squamous Cell Carcinoma | Skin Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Alpha DaRT
- description
- Alpha DaRT Seeds, Diffusing alpha-emitters Radiation Therapy.
- interventionNames
- Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
Primary outcomes (2)
- measure
- Adverse Events
- timeFrame
- 30-45 days post seed insertion
- description
- The incidence, severity and frequency of all Adverse Events
- measure
- Reduction in Tumor size
- timeFrame
- 30-45 days post seed insertion
- description
- The reduction in tumor size 30-45 days after DaRT insertion
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects with histopathological confirmation of skin squamous cell carcinoma before surgical removal of the tumor. * Subjects with a tumor size ≤ 5 centimeters in the longest diameter (lesions without nodal spread). * Subjects' age is over 18 years old. * Subjects' ECOG Performance Status Scale is ≤ 2. * Subjects' life expectancy is more than 6 months. * Female subjects of childbearing age will have evidence of negative pregnancy test. * Subjects are willing to sign an informed consent form. Exclusion Criteria: * Subject has a tumor with a maximal diameter \> 5 centimeters. * Subject has an ulcerative lesion. * Subject has a tumor of Keratoacanthoma histology. * Subjects' ECOG Performance Status Scale is ≥ 3. * Patients with moribund diseases, e.g., autoimmune diseases, vasculitis, etc. * Patients under immunosuppressive and/or corticosteroid treatment. * Volunteers that participated in other studies in the past 30 days that might affect the evaluation of response or toxicity of DaRT. * Pregnant women. * Subjects not willing to sign an informed consent form.
References
Publications (0)
Data not yet available
No reference posted for this study.