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

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.

Study Overview

• Status: Recruiting
• Conditions: Serous Cystadenoma
• Intervention / Treatment: Diagnostic test: SMI imaging

Detailed Description

Pancreatic cysts are becoming increasingly common in the general population. They are most often discovered incidentally during cross-sectional abdominal imaging.

There are different types of pancreatic cystic lesions, each with distinct risks of progression. Lesions with the potential for malignant transformation are typically mucinous lesions (papillary intraductal mucinous neoplasms of the pancreas [PIMN] and mucinous cystic neoplasms [MCN]), formerly known as mucinous cystadenomas), whereas non-mucinous lesions (serous cystadenomas [SCs] and pseudocysts) are entirely benign and do not require monitoring.

SC typically presents as a solitary cyst with no communication with the Wirsung duct, appearing microcystic with central calcification. This typical appearance is not always present, and SC can mimic a mucinous lesion. In such cases, imaging and echoendoscopy findings are not discriminatory. Histological and biochemical analysis of the fluid obtained during cyst aspiration may be helpful, but the specificity is usually insufficient to make a definitive decision regarding the absence of surgery and the need for monitoring. These diagnostic difficulties mean that one in three patients with SC undergo unnecessary surgery, with significant morbidity and mortality.

There are currently two highly effective techniques for diagnosing SC:

• Endocystic microbiopsy, which has a diagnostic accuracy of nearly 100% but a high complication rate (around 10%). It is no longer recommended except in exceptional cases.
• Needle-based confocal laser endomicroscopy (nCLE), which has 100% specificity for the diagnosis of SC.

SC is a lesion characterised by intense microvascularisation present in all the cyst walls and throughout the entire peripheral capsule of the cyst. SMI is a new ultrasound modality capable of visualising microvascular flow without the need for contrast injection, 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 Aplio i800 EUS console (Canon-Olympus).

To date, no data has been published on the potential of SMI for characterising and diagnosing SC. This is why this clinical investigation is being conducted.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Bertrand NAPOLEON, MD; Phone Number: + 33 4 78 75 67 43; Email: dr.napoleon@wanadoo.fr

Study Locations

• France
  • Lyon, France, 69008
    • Recruiting
    • Hopital Prive Jean Mermoz
    • Contact: Bertrand NAPOLEON, MD; Phone Number: + 33 4 78 75 67 43; Email: dr.napoleon@wanadoo.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SMI group; Intervention involves acquiring B-mode images of the pancreatic cyst using SMI	Diagnostic test: SMI imaging; B-mode imaging of pancreatic cysts with SMI using the new Aplio i800 EUS console (Canon-Olympus)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SMI specificity	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.	Day 0

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027

Study Registration Dates

• First Submitted: June 13, 2026
• First Submitted That Met QC Criteria: June 13, 2026
• First Posted (Actual): June 18, 2026

Study Record Updates

• Last Update Posted (Actual): June 18, 2026
• Last Update Submitted That Met QC Criteria: June 13, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: SMI; serous cystadenoma
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenoma; Neoplasms, Cystic, Mucinous, and Serous; Cystadenoma; Cystadenoma, Serous
• Other Study ID Numbers: 2026-A00624-47

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No