Pancreas Adenocarcinoma (MSI-H)SMILENCT07274657
Superb Microvascular Imaging (SMI) and Two-Dimensional Endoscopic Ultrasound Guided Shear Wave Elastography (2D-SWE-EUS) in Differential Diagnosis of Pancreatic Adenocarcinoma (PA) From Other Pancreatic Solid Lesions (PSLs) and Pancreatic neuroendocrinE Tumors (pNETs) Malignancy
A study testing SMI and 2D-SWE modes in people with Pancreas Adenocarcinoma (MSI-H) and Pancreatic Neuroendocrine Tumors (pNET), run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
Pancreatic adenocarcinoma (PA) is the most common tumor of the pancreas. Given its poor prognosis and the major therapeutic consequences, the discrimination between PA and other pancreatic solid lesions is mandatory. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Adenocarcinoma (MSI-H), Pancreatic Neuroendocrine Tumors (pNET)
- What is being tested?
- SMI and 2D-SWE modes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 24 Feb 2026to 30 Jun 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient, male or female, age ≥ 18 years old
- Patient with diagnosed pancreatic solid or mixed (cystic component ≤25 % of tumor volume) lesion
- Patient with adequate understanding of written and spoken French, able to sign written informed consent
- Patient affiliated with a social security system
Who cannot join
- Pregnant or breastfeeding woman
- Patient with usual contraindications to EUS- TA
- Patient with usual contraindications to SonoVue® administration
- Patient with a genetic syndrome associated pancreatic lesion (multiple neuroendocrine neoplasia type 1 (MEN1), type 1 neurofibromatosis (NF), Von-Hippel Lindau (VHL) disease)
- Protected patient: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision.
- Patient unable to perform the monitoring
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpital Privé Jean Mermoz
Lyon, 69008
Rodica Gincul, MD, + 33 6 15 34 08 69, rodica_h13@yahoo.fr
About this study
Pancreatic adenocarcinoma (PA) is the most common tumor of the pancreas. Given its poor prognosis and the major therapeutic consequences, the discrimination between PA and other pancreatic solid lesions is mandatory.
Endoscopic ultrasound (EUS) is admitted as the most sensitive imaging procedure for the detection and characterization of pancreatic tumors. Over the past 30 years, EUS-guided tissue acquisition (EUS-TA), or more recently fine needle biopsy (EUS-FNB), has demonstrated its efficiency for tissue sampling and remains the gold standard for the pathologic diagnosis of pancreatic lesions.
Read more
The assessment of pancreatic tumor enhancement using ultrasound contrast agents (UCAs) in real time with imaging specific methods seems useful to improve their characterization either by contrast-enhanced EUS (CE-EUS) or, more recently, by contrast-harmonic EUS (CH-EUS). CH-EUS was already demonstrated useful to differentiate pancreatic adenocarcinoma from other pancreatic lesions.
EUS-Elastography (EUS-E) is another EUS image enhancement technique, which rational based on the difference in elasticity between the tissues. There are two types of elastographies: strain elastography (SE) and shear wave elastography (SWE). SE has proved useful for the characterization of pancreatic lesions and lymph nodes. However, this technique was demonstrated difficult to perform with adequate accuracy and reproducibility for pancreatic lesions and have many limitations. In some recent publications SWE was demonstrated moderate reliability.
Pancreatic neuroendocrine tumors (pNETs) are rare tumors, but according to the last epidemiological data, their incidence and prevalence are steadily rising.
Surgical resection is generally performed for pNETs due to their malignant potential. However, with increasing use of high-resolution conventional imaging, the significant incidence of small (≤ 2 cm) pancreatic neuroendocrine incidentaloma (pNET) has risen in recent decades.
EUS is recognized as the most sensitive procedure for the detection and characterization of pNETs. Overall sensitivity of EUS-TA for the diagnosis of pNETs is high, reaching 95.1% in recently published study, appearing higher in small lesions (≤ 20 mm) than in large lesions (> 20 mm).
The overall concordance rate for EUS-TA and surgical specimens grading varies from 58% to 86.4% and is higher for lesions ≤ 10 mm, 10-20 mm, comparing to lesions > 20 mm. These results confirm the risk of under or over-grading of pNETs on the EUS-TA specimen, independently of the needle size which used for the TA.
CH-EUS was also demonstrated accurate in the prediction of pNETs malignancy and useful for decision-making management of these tumors.
Hypothesis
Two new image enhancement EUS technologies were recently developed, able to assess precisely tumor microvascular density and the stiffness of pancreatic lesions, that is correlated to tumor's stroma fibrosis, and thus help to characterize and predict the malignancy, and accordingly, the management of the pancreatic solid lesions. It's particularly useful in overcoming EUS false-negative cases of PA and small pNETs malignancy diagnosis.
Superb Microvascular Imaging (SMI) is a novel doppler technique that enhances the range of visible blood flow, by revealing low velocity microvascular flow, enabling the capture of a higher-quality microvascular flow images. Based on the same principle as CH-EUS, which assesses tumor microvascularization, this technique is expected to be also useful for the PSLs malignancy diagnosis.
Shear Wave Elastography (SWE) relies on the properties of shear-wave propagation to offer an advanced assessment of their velocity
Read the detailed description
Pancreatic adenocarcinoma (PA) diagnosis
Pancreatic adenocarcinoma (PA) is the most common tumor of the pancreas, representing more than 90% of all solid pancreatic neoplasia and 55% -73% of solid pancreatic masses. Given its poor prognosis and the major therapeutic consequences, the discrimination between PA and other pancreatic solid lesions is mandatory.
Endoscopic ultrasound (EUS) is admitted as the most sensitive imaging procedure for the detection and characterization of pancreatic tumors. Based on only endosonographic features, it remains difficult to differentiate PA from other solid masses, the specificity (Spe) and accuracy of EUS for the diagnosis of pancreatic tumor malignancy range from 53-69% and 72-83%, respectively.
Over the past 30 years, EUS-guided tissue acquisition (EUS-TA), or more recently fine needle biopsy (EUS-FNB), has demonstrated its efficiency for tissue sampling and remains the gold standard for the pathologic diagnosis of pancreatic lesions.
Although several prospective randomized studies and meta-analyses have shown that FNB needles are significantly superior to FNA needles for the diagnosis of solid pancreatic tumors, the overall accuracy remains insufficient to rule out malignancy. Additional diagnostic criteria are then required.
The assessment of pancreatic tumor enhancement using ultrasound contrast agents (UCAs) in real time with imaging specific methods seems useful to improve their characterization either by contrast-enhanced EUS (CE-EUS) or, more recently, by contrast-harmonic EUS (CH-EUS). Contrast harmonic EUS (CH-EUS), was already demonstrated useful to differentiate pancreatic adenocarcinoma from other pancreatic lesions.
EUS-Elastography (EUS-E) is another EUS image enhancement technique, which rational based on the difference in elasticity between the tissues. There are two types of elastographies: strain elastography (SE) and shear wave elastography (SWE). Strain elastography has proved useful for the characterization of pancreatic lesions and lymph nodes. However, this technique was demonstrated difficult to perform with adequate accuracy and reproducibility for pancreatic lesions and have many limitations. In some recent publications SWE was demonstrated moderate reliability.
Pancreatic neuroendocrine tumors (pNETs)
Pancreatic neuroendocrine tumors (pNETs) are rare tumors, but according to the last epidemiological data, their incidence and prevalence are steadily rising.
Surgical resection is generally performed for pNETs due to their malignant potential. However, with increasing use of high-resolution conventional imaging, the significant incidence of small (≤ 2 cm) pancreatic neuroendocrine incidentaloma (pNET) has risen in recent decades. Given their unknown natural history due to the lack of literature, the significant morbidity and mortality of pancreatic surgery, the current French and European Neuroendocrine Tumor Society (ENETS) Guidelines suggests that conservative management may also be considered for the small size (≤ 2 cm) nonfunctional, asymptomatic and without criteria for malignancy pNETs, classified as G1 or low G2 according to the 2019 World Health Organization (WHO) classification system lesion, after multidisciplinary discussion and patient counseling.
EUS is recognized as the most sensitive procedure for the detection and characterization of pNETs. Overall sensitivity of EUS-TA for the diagnosis of pNETs is high, reaching 95.1% in recently published study, appearing higher in small lesions (≤ 20 mm) than in large lesions (> 20 mm).
The overall concordance rate for EUS-TA and surgical specimens grading varies from 58% to 86.4% and is higher for lesions ≤ 10 mm, 10-20 mm, comparing to lesions > 20 mm. These results confirm the risk of under or over-grading of pNETs on the EUS-TA specimen, independently of the needle size which used for the TA.
CH-EUS was also demonstrated accurate in the prediction of pNETs malignancy and useful for decision-making management of these tumors.
Hypothesis
Two new image enhancement EUS technologies were recently developed, able to assess precisely tumor microvascular density and the stiffness of pancreatic lesions, that is correlated to tumor's stroma fibrosis, and thus help to characterize and predict the malignancy, and accordingly, the management of the pancreatic solid lesions. It's particularly useful in overcoming EUS false-negative cases of PA and small pNETs malignancy diagnosis.
Superb Microvascular Imaging (SMI) is a novel doppler technique that enhances the range of visible blood flow, by revealing low velocity microvascular flow, enabling the capture of a higher-quality microvascular flow images. Based on the same principle as CH-EUS, which assesses tumor microvascularization, this technique is expected to be also useful for the PSLs malignancy diagnosis.
Shear Wave Elastography (SWE) relies on the properties of shear-wave propagation to offer an advanced assessment of their velocity and tissue elasticity, presenting the results quantitatively in a dynamic display.
The new developed image enhancement EUS technologies, SMI and 2D-SWE-EUS now available on the new Aplio i800 EUS unit (Canon-Olympus).
Given the lack of published data in the literature regarding the utility of SMI and 2D-SWE-EUS, it is essential to assess the performance of these two techniques in the differential diagnosis of SPLs and pNETs malignancy
- Being tested
- SMI and 2D-SWE modes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMI and 2D-SWE modesDevice
SMI and 2D-SWE are new imaging modes on the new Aplio i800 EUS Unit (Canon Olympus - CE marked)
| Study group | Role | What they receive |
|---|---|---|
| New imaging arm | Experimental | New imaging arm involves characterization and diagnosis of PA and pNETs malignancy, using the linear-array EUS scope UCT-180 Olympus and the new Aplio i800 EUS Unit (Canon Olympus - CE marked) equipped with a SMI and 2D-SWE modes Receives: Device: SMI and 2D-SWE modes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Independent sensitivity assessment of each imaging technique, EUS-SMI, 2D-SWE-EUS and CH-EUS, according to final histopathological diagnosis for the diagnostic of PA
Sensitivity is defined as the number of true positives (positive diagnoses in patients with PA) divided by the total number of patients with PA. The presence or absence of PA will be revealed by a final diagnosis based on:
- The cyto-pathological result obtained by EUS-TA of the pancreatic lesion or the histo-pathological result obtained by surgery (if performed).
And
- Clinical follow-up data for 12 months: doubling in size of the primary tumor during the follow-up and/or vascular invasion and/or appearance of lymph nodes and/or distant metastases
Measured: 12 months after EUS (Endoscopic ultrasound)-guided tissue acquisition (EUS-TA)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start24 Feb 2026
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas Adenocarcinoma (MSI-H)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la Recherche
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07274657
- Sponsor's protocol ID
- 2025-A01725-44
- Acronym
- SMILE
- Status last verified
- Aug 2026
- First submitted
- 23 Nov 2025
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No