Clinical trial · Interventional
Initial Feasibility Study to Treat Resectable Pancreatic Cancer With a Planar LDR Source
Initial Feasibility Study to Treat Resectable Pancreatic Cancer With the Permanently Implantable LDR CivaSheet®
NCT03109041CI-TRIAL-00069464completedPhase 1ClinicalTrials.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)
This is a Phase I evaluation to determine the usefulness of a new brachytherapy device that utilizes active components (Palladium-103) of standard devices in a novel configuration. This study may benefit resectable pancreatic cancer patients by reducing the radiation dose to adjacent critical structures, while giving a therapeutic dose to diseased tissue, such as at a surgical margin.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Pancreas Cancer | Pancreatic Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CivaSheet | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Directional Brachytherapy Source Implant
- description
- Patients undergoing a whipple procedure for pancreatic cancer will receive an implant at the time of surgery of the new CivaSheet directional brachytherapy device. The directional nature of the FDA cleared CivaSheet is expected to allow physicians to increase the radiation dose given to the surgical margin safely, reducing risk of recurrence without increasing radiation side effects.
- interventionNames
- Device: CivaSheet
Primary outcomes (1)
- measure
- Safety & Toxicity of Delivering Primary Radiation Therapy with CivaSheet using the CTCAE 4.0 scale
- timeFrame
- 1.5 years
- description
- Patients with resectable pancreatic cancer who are undergoing pancreatic cancer resection will be monitored for safety \& toxicities graded using the CTCAE 4.0 scale.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subject signed informed consent * Age \>/= 18 years * Biopsy confirmed adenocarcinoma pancreatic cancer * Patient capable of undergoing anesthesia * Patient is a surgical candidate * Patient selected to undergo pancreatic cancer resection * Patient will have known or suspected close/positive surgical margin * Confirmed diagnosis of resectable pancreatic adenocarcinoma * Will be prescribed standard Gemcitabine 1000 mg/m2 chemotherapy cycle Exclusion Criteria: * Pregnant or breast feeding * Patient has metastatic disease * Patient has had prior radiation therapy to the region for separate cancer * Patient has had prior chemotherapy * Any other invasive cancer in the past 5 years, except basal cell skin * Recurrent or previously resected tumors * Alcoholism/Drug abuse
References
Publications (0)
Data not yet available
No reference posted for this study.