NCT07657884Recruiting
Assessment of the Usefulness of SMI (Superb Vascular Imaging) for the Characterisation of Pancreatic Cystic Tumours (IMAKYST)
Source: ClinicalTrials.gov · Last updated 18 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 13 Jun 2026
- Start date
- 15 May 2026
- Primary completion date
- 30 Nov 2027
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la Recherche
- Diseases
- Pancreatic cancer
- NCT number
- NCT07657884
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 15 May 2026 to the primary completion date, 30 Nov 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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)
Other
- Patient with calcifying chronic pancreatitis
- Presence of a communication with the main pancreatic duct on MRI or endoscopic ultrasound
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpital Privé Jean Mermoz Coordinator of this site? Confirm its status | Lyon | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.