Assessment of the Usefulness of SMI (Superb Vascular Imaging) for the Characterisation of Pancrea… (NCT07657884) | Clinical Trial Compass
RecruitingNot Applicable
Assessment of the Usefulness of SMI (Superb Vascular Imaging) for the Characterisation of Pancreatic Cystic Tumours (IMAKYST)
France60 participantsStarted 2026-05-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
SMI specificity
Timeframe: Day 0
Trial details
NCT IDNCT07657884
SponsorGCS Ramsay Santé pour l'Enseignement et la Recherche