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

NCT07657884 | Recruiting

• 1 other identifier: 2026-A00624-47
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Serous Cystadenoma

Keywords

SMI; serous cystadenoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

SMI group

EXPERIMENTAL

Intervention involves acquiring B-mode images of the pancreatic cyst using SMI

Diagnostic Test: SMI imaging

Interventions

SMI imaging DIAGNOSTIC_TEST

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

SMI group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Hôpital Privé Jean Mermoz

Lyon, 69008, France

RECRUITING

MeSH Terms

Conditions

Cystadenoma, Serous

Condition Hierarchy (Ancestors)

Cystadenoma; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Cystic, Mucinous, and Serous

Central Study Contacts

Bertrand NAPOLEON, MD

CONTACT

+ 33 4 78 75 67 43; dr.napoleon@wanadoo.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2026
• First Posted: June 18, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: June 18, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)