Clinical trial · Interventional
Alpha Radiation Emitters Device for the Treatment of Cutaneous, Mucosal and Superficial Soft Tissue Neoplasia (DaRT)
A Safety and Preliminary Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters on Cutaneous, Mucosal and Superficial Soft Tissue Neoplasia
NCT03886181CI-TRIAL-00098618terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Difficulties in recruitment and the site's resources to recruit patients
Summary
Brief summary (as posted)
A unique approach for cancer treatment employing intratumoral diffusing alpha radiation emitter device for superficial cutaneous, mucosal or soft tissue neoplasia
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 |
|---|---|---|---|
| Mucosal Neoplasm of Oral Cavity | — | UNRESOLVED | — |
| Skin Cancer | Malignant Skin Neoplasm | ALIAS | 0.90 |
| Soft Tissue Neoplasm | Soft Tissue Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- DaRT Seeds
- description
- Intratumoral Diffusing alpha-emitters Radiation Therapy (DaRT) Seeds
- interventionNames
- Device: Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
Primary outcomes (1)
- measure
- Evaluate the safety of the DaRT treatment
- timeFrame
- 5-7 weeks after DaRT seed insertion.
- description
- The study primary objective is to evaluate the safety of the DaRT treatment in terms of incidence of device related Serious Adverse Events (SAE).
Secondary outcomes (1)
- measure
- Evaluation the effectiveness of the treatment.
- timeFrame
- Tumor volume will be measured during screening, 5 and 30-45 days post DaRT after treatment using CT.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects with histopathological confirmation of cutaneous and/or mucosal and/or superficial soft tissue malignant neoplasia. * Subjects with a tumor size ≤ 5 centimeters in the longest diameter. * Subjects' age is over 18 years old. * Subjects' ECOG Performance Status Scale is \< 2. * Subjects' life expectancy is more than 6 months. * Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test. * Subjects are able and willing to sign an informed consent form. Exclusion Criteria: * Subject has a tumor with a maximal diameter \> 5 centimeters. * Subjects' ECOG Performance Status Scale is \> 3. * Subject has a tumor of Keratoacanthoma histology. * Patients with moribund diseases, e.g., autoimmune diseases, vasculitis, etc. * Patients under systemic immunosuppressive and/or corticosteroid treatment. Patients taking corticosteroid inhalers are eligible.
References
Publications (0)
Data not yet available
No reference posted for this study.