Clinical trial · Interventional
Alpha Radiation Emitters Device for the Treatment of Advanced Pancreatic Cancer
A Feasibility and Safety Study of Intratumoral Diffusing Alpha Radiation Emitters on Advanced Pancreatic Cancer
NCT04002479CI-TRIAL-00098257active not recruitingN/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 advanced pancreatic cancer.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
| Pancreatic Adenocarcinoma | Pancreatic Adenocarcinoma | ONTOLOGY_EXACT | 0.98 |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Unresectable Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_BROADER | 0.78 |
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 (3)
- measure
- Feasibility - DaRT seed placement
- timeFrame
- Day 0 (Day of insertion)
- description
- Assessment of the DaRT seed placement within the tumor or less than 5 mm from the tumor using CT imaging on the day of DaRT insertion.
- measure
- Safety - Adverse events
- timeFrame
- 3 months
- description
- Assessment of the frequency, severity and causality of acute AEs and SAEs related to DaRT seeds insertion. AEs and SAEs will be assessed and graded according to Common Terminology and Criteria for Adverse Events (CTCAE) version 5.0
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically and/or cytologically proven locally advanced (Stage II or III) or metastatic (Stage IV) pancreatic, adenocarcinoma * Inoperable pancreatic cancer due to at least one of the following: a) unresectability, b) metastatic disease, c) medically unfit for surgery * ECOG performance status ≤ 2 * Measurable lesion per RECIST (version 1.1) criteria * Maximum lesion of 4cm in the longest diameter (including primary tumor and regional lymph nodes) * ≥ 18 years of age * Estimated life expectancy of at least 12 weeks * Women of childbearing potential (WOCBP) will have evidence of negative pregnancy test * Subjects are willing to sign an informed consent Exclusion Criteria: * Prior chemotherapy does not exclude the patient * Prior abdominal radiation therapy * Concomitant chemotherapy or immunotherapy * Borderline resectable pancreatic cancer and medically fit for surgery * Connective tissue disease (scleroderma, lupus) * 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) * Patients not willing to sign an informed consent form * Women who are pregnant or lactating
References
Publications (0)
Data not yet available
No reference posted for this study.