Not yet recruitingNAINTERVENTIONAL

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

This study aims to improve how doctors tell the difference between common pancreatic cancer (pancreatic adenocarcinoma) and other types of growths, including rare neuroendocrine tumours. These differences are vital for deciding the best treatment. Currently, doctors often use special ultrasound (EUS) to examine the pancreas and take biopsies. However, it can sometimes be difficult to get a perfectly clear picture. This research is testing two new advanced ultrasound methods, called Superb Microvascular Imaging (SMI) and Shear Wave Elastography (SWE). SMI helps doctors see tiny blood vessels within growths, and SWE measures how stiff they are. These techniques could make it easier to identify the type of growth more accurately, avoiding unnecessary procedures or ensuring timely treatment.

At a glance

Status

Not yet recruiting

Phase

Sponsor

GCS Ramsay Santé pour l'Enseignement et la Recherche

Enrolment target

150

Start

01 Jan 2026

Estimated completion

30 Jun 2028

Pancreas Adenocarcinoma (MSI-H)Pancreatic Neuroendocrine Tumors (pNET)

What is this study about?

Imagine the pancreas as a delicate organ that can sometimes develop growths. These growths aren't all the same; some are more serious than others. For instance, pancreatic adenocarcinoma (PA) is the most common and often requires swift treatment, while pancreatic neuroendocrine tumours (pNETs) are rarer and might be managed differently. Telling these apart accurately is incredibly important for doctors to choose the right path for your care.

Currently, doctors often use a procedure called endoscopic ultrasound (EUS). This involves a thin, flexible tube with a tiny camera and ultrasound device at its tip, guided down your throat to get a close look at the pancreas. They might also take a small tissue sample (biopsy) to examine under a microscope. While this is very helpful, sometimes it's still tricky to be absolutely certain of the growth's nature, especially if it's small, or to fully understand its aggressiveness.

This study is exploring two exciting new ultrasound techniques that work alongside EUS: Superb Microvascular Imaging (SMI) and Shear Wave Elastography (SWE). SMI is like having an extra-sensitive pair of eyes for blood flow; it helps doctors see the tiny blood vessels inside a growth more clearly, which can give clues about its type. SWE, on the other hand, measures how stiff or soft a growth is – much like how you might press on a fruit to see if it's ripe. Different types of growths have different stiffnesses. The hope is that by using these advanced tools, doctors can get a much clearer and more detailed picture without always needing additional biopsies, leading to faster and more accurate diagnoses.

Key takeaways

This study uses new ultrasound methods to better identify pancreatic growths.
It aims to improve diagnosis of common pancreatic cancer and rare neuroendocrine tumours.
The new techniques, SMI and SWE, look at blood flow and stiffness of growths.
Better imaging may lead to more accurate diagnoses and tailored treatment plans.
Participation involves an advanced endoscopic ultrasound (EUS) procedure.

Who may be eligible?

To be part of this study, you need to be at least 18 years old and have been diagnosed with a solid or mixed growth in your pancreas. This means the growth shouldn't be mostly fluid-filled (less than a quarter of its volume should be fluid).

You'll also need to understand French well enough to follow all instructions and sign a consent form, and be registered with a social security system. Unfortunately, if you are pregnant or breastfeeding, or have certain other existing health conditions or situations that prevent you from having an EUS-guided procedure or receiving a special ultrasound fluid called SonoVue®, you won't be able to join. This also applies if you have a known genetic condition linked to pancreatic growths, like MEN1.

Additionally, if you are under guardianship, in legal protection, or unable to attend follow-up appointments, you wouldn't be able to participate. This ensures everyone in the study can complete it safely and successfully.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have a solid or mostly solid growth in your pancreas?
Can you understand and speak French well enough to give consent?
Are you not pregnant or breastfeeding?
Do you not have a genetic condition known to cause pancreatic growths (like MEN1)?
Are you able to attend all planned appointments?

Answer every question to see your result.

What does participation involve?

If you join this study, you will undergo standard endoscopic ultrasound (EUS) which involves a thin, flexible tube with a camera and ultrasound probe being passed down your throat to your pancreas. During this procedure, the researchers will use the two new ultrasound techniques, Superb Microvascular Imaging (SMI) and Shear Wave Elastography (SWE), to gather more detailed images of your pancreatic growth. You may also receive a special ultrasound contrast agent called SonoVue® which helps improve the clarity of the images. The study does not involve new medications, and the procedures are similar to what you might already have for diagnosis. Your participation will involve the EUS procedure and any necessary follow-up appointments as determined by your medical team. The total duration of your involvement will depend on your individual diagnostic and treatment pathway.

Potential risks and benefits

Taking part in this study may offer the benefit of a more precise diagnosis for your pancreatic growth using advanced ultrasound techniques, potentially helping doctors make better treatment decisions for you. While these new techniques are part of an existing routine procedure, there are potential risks associated with the endoscopic ultrasound procedure itself, such as discomfort, sedation risks, or, in rare cases, complications like bleeding or infection. You will be closely monitored by medical staff throughout the process. Remember, you can choose to stop participating in the study at any time without affecting your ongoing medical care.

Locations (1)

Hôpital Privé Jean Mermoz
Verified postcode
Lyon, France

Common questions

What is the pancreas?

The pancreas is an organ behind your stomach that helps digest food and control blood sugar.

What are pancreatic growths?

These are unusual lumps or areas of tissue that can develop in the pancreas. They can be harmless or serious.

What is EUS (Endoscopic Ultrasound)?

It's a procedure where a doctor uses a special flexible tube with an ultrasound on the end to get a close look at your pancreas.

Are SMI and SWE new treatments?

No, SMI and SWE are new imaging techniques that help doctors get a clearer picture of growths, not treatments themselves.

Will this study change my current treatment plan?

The information gathered from this study could help your doctors make better decisions about your treatment, but the study itself doesn't provide treatment.

How to find out more

Rodica Gincul, MD

rodica_h13@yahoo.fr + 33 6 15 34 08 69 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.