Clinical trial · Interventional
Alpha Radiation Emitters Device for the Treatment of Squamous Cell Carcinoma
A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters on Squamous Cell Carcinoma (First in Man)
NCT03015883CI-TRIAL-00049398DaRTcompletedN/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.
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 |
|---|---|---|---|
| Squamous Cell Carcinoma | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diffusing Alpha Radiation Emitters Therapy (DaRT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Diffusing Alpha Radiation Emitters Therapy (DaRT)
- description
- Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seed Devices
- interventionNames
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Histopathological confirmation of squamous cell carcinoma. 2. Tumor size ≤ 5 centimeters in the longest diameter. 3. Age over 18. 4. Women of childbearing potential will have evidence of negative pregnancy test. 5. Life expectancy of more than 6 months. 6. Performance status 2 (ECOG scale) or less. 7. Signed informed consent form. Exclusion Criteria: 1. Tumor maximal diameter \> 5 centimeters. 2. Tumor of Keratoacanthoma histology. 3. Performance status ≥ 3 (ECOG scale). 4. Patients with moribund diseases, autoimmune diseases or vasculitis. 5. Patients under immunosuppressive and/or corticosteroid treatment. 6. Volunteers that participated in other studies in the past 30 days.
References
Publications (0)
Data not yet available
No reference posted for this study.