Clinical trial · Interventional
Endoscopic Ultrasound Guided Fine Needle Biopsy (EUS-FNB-SC) Using a Novel Fork Needle
Pilot-Feasibility Trial of EUS Guided Pancreas Fine Needle Core Biopsy for Whole Exome Sequencing and Genomic Profiling
- 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 clinical trial to compare two needles used in biopsy techniques to acquire tissue from pancreatic cancer. The hypothesis is that the tissue yield, as measured by tumor DNA and cellular material is superior for Flexible Needle Biopsy (FNB) compared with conventional Fine Needle Aspiration (FNA). Specifically, FNB will increase the proportion of cases in which sufficient DNA is obtained to allow genomic profiling and whole exome sequencing.
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 |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fine Needle Aspiration (FNA) | Device | — | UNRESOLVED |
| Fine Needle Biopsy (FNB) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- FNB first, then FNA
- description
- In an endoscopic ultrasound-guided procedure, Shark Core Fine Needle Biopsy (FNB) will be performed first, followed by Fine Needle Aspiration (FNA).
- interventionNames
- Device: Fine Needle Biopsy (FNB)
- Device: Fine Needle Aspiration (FNA)
- type
- ACTIVE_COMPARATOR
- label
- FNA first, then FNB
- description
- In an endoscopic ultrasound-guided procedure, Fine Needle Aspiration (FNA) will be performed first, followed by Shark Core Fine Needle Biopsy (FNB).
- interventionNames
- Device: Fine Needle Biopsy (FNB)
- Device: Fine Needle Aspiration (FNA)
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Male and female patients who are 18 years old or older and are referred for the evaluation of pancreatic mass lesion. * International Normalized Ratio (INR) less than 1.5 and platelet count of more than 50,000. * Medically stable to undergo sedation for EUS. * Signed informed consent Exclusion Criteria: * Medical condition that preclude the patient from having a therapeutic procedure regardless of the EUS finding * Pregnant patients
References
Publications (0)
Data not yet available