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Assessment of SMI (Superb Microvascular Imaging) for Characterising the Endocystic Material of Papillary Intraductal Mucinous Pancreatic Tumours (PIMPT)

NCT07663734 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2026-07
Last updated
2026-06-23

Condition(s) studied

Papillary and Mucinous Intraductal Tumours of the Pancreas

Investigational drug(s) / intervention(s)

SMI (Superb Microvascular Imaging)

SMI (Superb Microvascular Imaging): Imaging of endocystic material within PIMPT in SMI, using the new Aplio i800 EUS console (Canon-Olympus)

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • SMI sensitivity — Day 0
    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

Trial sites (1)

FacilityCityRegionStatus
Hôpital Privé Jean Mermoz Lyon France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07663734 on ClinicalTrials.gov ↗ ← All trials in France