Clinical trial · Observational
Clinical Registry of nCLE in Masses and Cystic Tumors of the Pancreas, Lymph Nodes, Submucosal Lesions of the GI Tract
Registry Trial for Clinical Evaluation of nCLE in Masses and Cystic Tumors of the Pancreas, Lymph Nodes, Submucosal Lesions of the GI Tract
- 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 study focuses on four different lesions: pancreatic cysts, lymph nodes near the gastrointestinal tract, pancreatic masses and GIST tumors. On one hand, the results obtained during previous studies are more advanced for the assessment of the diagnostic performance of Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system for Pancreatic cysts. Safety and technical feasibility have already been performed, and an interpretation criteria classification exists. On the other hand, results for pancreatic masses, Lymph nodes and GIST are less developed. the objectives of the study are to * Assess the diagnostic performance of the Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system in diagnosing masses and cystic tumors of the pancreas, lymph nodes, submucosal lesions of the GI tract * Define/Validate descriptive criteria of nCLE sequences in masses and cystic tu-mors of the pancreas, lymph nodes, submucosal lesions of the GI tract
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| GIST | Gastrointestinal Stromal Tumor | ALIAS | 0.90 |
| Lymphadenopathy | — | UNRESOLVED | — |
| Lymph Node Mass | — | UNRESOLVED | — |
| Pancreatic Adenoma | — | UNRESOLVED | — |
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
| Pancreatic Cyst | — | UNRESOLVED | — |
| Pancreatic Islet Cell Tumors | — | UNRESOLVED | — |
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic ultrasound fine needle aspiration | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- pancreatic cysts
- description
- Patient indicated for a first endoscopic ultrasound fine needle aspiration (EUS-FNA) for a pancreatic cyst,
- interventionNames
- Device: Endoscopic ultrasound fine needle aspiration
Primary outcomes (1)
- measure
- performance evaluation
- timeFrame
- up to one year
- description
- * Assess the diagnostic performance of the Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system in diagnosing masses and cystic tumors of the pancreas, lymph nodes, submucosal lesions of the GI tract (accuracy evaluation) * Define/Validate descriptive criteria for nCLE sequences in the characterization of masses and cystic tumors of the pancreas, lymph nodes, submucosal lesions of the GI tract (image interpretation criteria definition
Secondary outcomes (1)
- measure
- Safety and feasibility evaluation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * \- Male or female \> 18 years of age * Patient indicated for a first EUS-FNA for masses and cystic tumors of the pancreas, lymph nodes, submu-cosal lesions of the GI tract * Patients who had previous non-diagnostic tissue sampling taken during a previous EUS-FNA for masses and cystic tumors of the pancreas, lymph nodes, submucosal lesions of the GI tract * Patient with known masses and cystic tumors of the pancreas, lymph nodes, submucosal lesions of the GI tract * For pancreatic cyst patient, suffering chronic calcifying pancreatitis * For pancreatic mass patient, any size or location * For lymph node patient, any node reachable with EUS-FNA * Willing and able to comply with study procedures and provide written informed consent to participate in the registry Exclusion Criteria: * \- Subjects for whom EUS-FNA procedures are contraindicated * Known allergy to fluorescein contrast * If female, breast feeding or pregnant based on a positive hCG serum or an in vitro diagnostic test result * Subject with multiple cysts * Cysts \<20 mm in diameter * Previous EUS-FNA procedure performed less than 3 months ago * If several pancreatic masses, only one will be imaged during the nCLE procedure * Lymph nodes \<5 mm in diameter * If several suspicious lymph nodes, only the most suspect will be imaged during the nCLE proce-dure
References
Publications (0)
Data not yet available