Clinical trial · Interventional
Alpha Radiation Emitters Device (DaRT) for the Treatment of Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia.
A Safety and Effectiveness Study of Intratumoral Diffusing Alpha Radiation Emitters for the Treatment of Malignant Cutaneous, Mucosal or Superficial Soft Tissue Neoplasia
NCT03889899CI-TRIAL-00098178recruitingN/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 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 |
|---|---|---|---|
| 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: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)
Primary outcomes (2)
- measure
- Tumor response to DaRT
- timeFrame
- 9-11 weeks after DaRT seed insertion.
- description
- Assessment of the rate of malignant cutaneous, mucosal or superficial soft tissue tumors response using the Response Evaluation Criteria in Solid Tumors (RECIST) (Version 1.1)
- measure
- Adverse Events
- timeFrame
- Time Frame: 9-11 weeks post DaRT insertion.
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects with histopathological confirmation of primary or secondary malignant cutaneous neoplastic lesions, or oral cavity mucosal tumors, or superficial soft tissue sarcoma. * Subjects with a tumor size ≤ 7 centimeters in the longest diameter. * 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. * Creatinine ≤1.9 mg/dL. * 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 of Keratoacanthoma histology. * 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.