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Clinical Trials in France / NCT07657884
Recruiting Not applicable

Assessment of the Usefulness of SMI (Superb Vascular Imaging) for the Characterisation of Pancreatic Cystic Tumours (IMAKYST)

NCT07657884 · tracked via the Priya Life Science France tracker
Sponsor
GCS Ramsay Santé pour l'Enseignement et la Recherche
Phase
Not applicable
Started
2026-05-15
Last updated
2026-06-18

Condition(s) studied

Serous Cystadenoma

Investigational drug(s) / intervention(s)

SMI imaging

SMI imaging: B-mode imaging of pancreatic cysts with SMI using the new Aplio i800 EUS console (Canon-Olympus)

Study summary

A cystic lesion is an abnormal cavity formed within tissue or an organ, which may contain a liquid, semi-solid or gaseous substance.

There are different types of pancreatic cystic lesions: lesions that may become cancerous and completely benign lesions that do not require monitoring, such as serous cystadenomas (SCs) and pseudocysts.

Diagnostic difficulties mean that one in three patients with a SC undergoes unnecessary surgery with significant morbidity and mortality (risk of death). Currently, needle-based confocal laser endomicroscopy (nCLE) is the gold standard technique for the diagnosis of SC.

SC is a lesion characterised by an extensive network of small blood vessels present in all the cyst walls and throughout the cyst's peripheral capsule. SMI (Superb Vascular Imaging) is a new ultrasound mode that improves the visibility of blood flow in the vessels without the injection of contrast medium (a diagnostic agent used for certain medical imaging examinations, most often administered intravenously), unlike nCLE.

The Mermoz Endoscopy Centre will be equipped with an ultrasound console enabling SMI to be performed during an echoendoscopy examination. This technology is now available on the new EUS Aplio i800 console (Canon-Olympus), which is CE marked.

To date, no data has been published on the potential of SMI to characterise and diagnose CS. 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 confocal microscopy (nCLE) assessment of a pancreatic cyst of unknown origin * Patient with a cyst measuring more than 15 mm in diameter and at least one cyst cavity measuring ≥ 5 mm (to allow nCLE to be performed) * Patient registered with or covered by the National Health Service * French-speaking patient who has signed an informed consent form Exclusion Criteria: * Patient with calcifying chronic pancreatitis * Presence of a communication with the main pancreatic duct on MRI or endoscopic ultrasound * Patient whose lesion meets criteria for malignancy (tissue mass, metastases, ascites, vascular infiltration) * Patient with a contraindication to endoscopic ultrasound-guided puncture (haemostatic disorder) * Patient with a known allergy to fluorescein (used in nCLE) * Pregnant woman * Patient under legal guardianship: adults under guardianship, curatorship or other legal protection, or deprived of their liberty by judicial or administrative order * Hospitalised patient without consent

Primary outcome measure(s)

  • SMI specificity — Day 0
    SMI specificity is expressed as a percentage. Specificity is defined as the number of true negatives (negative diagnoses in patients without SC) divided by the total number of patients without SC.

Trial sites (1)

FacilityCityRegionStatus
Hôpital Privé Jean Mermoz Lyon France Recruiting

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Other trials for the same condition

Feasibility of Molecular Biology in Pancreatic Cyst Tumors Active, not recruiting
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 NCT07657884 on ClinicalTrials.gov ↗ ← All trials in France