See if Superb Vascular Imaging helps characterize pancreatic serous cystadenomas
Official title: Assessment of the Usefulness of SMI (Superb Vascular Imaging) for the Characterisation of Pancreatic Cystic Tumours (IMAKYST)
Run by GCS Ramsay Santé pour l'Enseignement et la Recherche · NCT07657884 · Data updated 2026-11-12
This study tests whether a new ultrasound method called SMI can help doctors tell serous cystadenomas apart from other pancreatic cysts without needing invasive tests.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | GCS Ramsay Santé pour l'Enseignement et la Recherche Academic / other |
| Locations | 1 site (Lyon) |
| Status | Recruiting |
| Started | May 15, 2026 |
| Main results expected | November 30, 2027 |
| Study ends | November 30, 2027 |
| Registry record updated | June 18, 2026 |
| Trial ID | NCT07657884 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults referred for confocal microscopy assessment of a pancreatic cyst of unknown origin, with cysts meeting size criteria and French-speaking with consent.
✕Probably not a fit
Patients whose cysts are clearly benign or malignant by standard methods may not gain additional diagnostic benefit from SMI.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Pancreatic cysts are common and can be either benign or potentially dangerous. The study uses Superb Vascular Imaging (SMI), a noninvasive ultrasound technique, to visualize blood flow in cyst walls and assess its usefulness for classifying serous cystadenomas. Participants are adults referred for diagnostic testing of pancreatic cysts and who meet specific size and consent criteria. The trial focuses on diagnostic utility rather than treatment effects, using SMI as the imaging modality of interest. It examines whether SMI can reduce unnecessary procedures by improving accuracy in identifying benign cysts.
Why it matters
Potential benefit: If successful, SMI could improve noninvasive characterization of pancreatic cysts and reduce unnecessary surgeries.
How similar studies have gone: Other imaging techniques have shown promise for pancreatic cyst characterization, but SMI in this context is a newer approach with limited prior data.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Hôpital Privé Jean Mermoz
Lyon, France Recruiting
Study contacts
- Study coordinator: Bertrand NAPOLEON, MD
- Email: dr.napoleon@wanadoo.fr
- Phone: + 33 4 78 75 67 43
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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AI-guided diagnosis and management of pancreatic cysts using endoscopic ultrasound
This project will test an AI tool that uses EUS images plus CT/MRI and lab data to help doctors tell mucinous from non-mucinous pancreatic cysts and guide care for adults with pancreatic cystic lesions.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.