Clinical trial · Interventional
Assessment of SMI (Superb Microvascular Imaging) for Characterising the Endocystic Material of Papillary Intraductal Mucinous Pancreatic Tumours (PIMPT)
- 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)
There are many types of pancreatic cysts, and papillary intraductal mucinous pancreatic tumours (PIMPTs) are among the most common. PIMPTs carry a risk of progressing to a cancerous lesion. To assess this risk, the key examination involves performing an endoscopic ultrasound combined with an injection of a contrast agent called Sonovue. Superb Microvascular Imaging (SMI) is a new ultrasound modality that enables the analysis of PIMPTs without the need for a Sonovue injection. The Mermoz Endoscopy Centre will be equipped with an ultrasound console enabling SMI to be performed during an endoscopic ultrasound examination. This technology is now available on the new EUS Aplio i800 console (Canon-Olympus), which bears the CE mark. To date, no data have been published on the potential of SMI for analysing a PIMPT. This is why this clinical investigation is being conducted
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 |
|---|---|---|---|
| Papillary and Mucinous Intraductal Tumours of the Pancreas | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SMI (Superb Microvascular Imaging) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SMI group
- description
- Imaging of endocystic material within PIMPT in SMI, using the new Aplio i800 EUS console (Canon-Olympus)
- interventionNames
- Diagnostic Test: SMI (Superb Microvascular Imaging)
Primary outcomes (1)
- measure
- SMI sensitivity
- timeFrame
- Day 0
- description
- Sensitivity is defined as the number of true positives (positive diagnoses in patients with a tissue nodule) divided by the total number of patients with a tissue nodule
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient referred for an endoscopic ultrasound assessment of a PIMPT * Patient with endocystic material of undetermined nature measuring 3 mm or more * Patient registered with or covered by the social security scheme * Patient who speaks French * Patient who has signed an informed consent form Exclusion Criteria: * Patient whose lesion meets the criteria for malignancy (tissue mass, metastases, ascites, vascular infiltration) * Patient for whom Sonovue is contraindicated * Pregnant woman * Vulnerable patient: an adult under guardianship, curatorship or other legal protection, or deprived of their liberty by a judicial or administrative decision * Patient admitted to hospital without consent
References
Publications (0)
Data not yet available