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Can a new ultrasound technique spot hidden pancreatic cancers earlier?

NCT ID NCT06276764

Diagnosis Sponsor: Adenocyte, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 06, 2026 · Last updated Aug 07, 2026 · Updated 1 time

Summary

This study evaluates a new diagnostic procedure called LINFU® to see if it can detect early pancreatic cancer and precancerous changes (dysplasia) in people with intraductal papillary mucinous neoplasm (IPMN), a condition that raises the risk of pancreatic cancer. Participants will undergo a 15-minute low-intensity ultrasound of the pancreas, receive a contrast agent and secretin, and have pancreatic juice collected for analysis. The goal is to compare LINFU®'s detection rate with standard imaging methods like EUS, MRI, and CT, and to see if it leads to earlier intervention and better outcomes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
LINFU® (low-intensity non-focused ultrasound with contrast agent and secretin)
What this could lead to
If successful, this could lead to a new screening method that catches pancreatic cancer earlier, potentially improving treatment options and outcomes.
What could go wrong
This is a registry study, not a randomized trial, so results may not prove effectiveness. The procedure involves contrast agents and secretin, which carry risks of allergic reactions or other side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 500 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Dec 2034

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Patients with a documented history of IPMN by any imaging method.

Ages

18 to 90 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Both males and females will be enrolled and must be at least 18 years of age and under age of 90 2. Patients with a documented history of IPMN by any imaging method. 3. All patients must undergo contemporaneous imaging (within 90 days before or after the LINFU® procedure) with one or more of the following: EUS, CH-EUS, CEUS, MRI/MRCP, PET/CT, CT 4. Patients undergoing EUS-FNA may be enrolled but the FNA must be performed after the LINFU® procedure 5. Institutional Review Board (IRB)-approved consent must be signed by patients to participate in this study. Exclusion Criteria: 1. Patient under the age of 18 and over the age 90 2. Contraindications to LINFU® as determined by study investigators: 1. Patient with uncorrectable coagulopathy 2. Patient that cannot undergo anesthesia due to cardiopulmonary contraindication as deemed by the anesthesiologist 3. Unstable medically (cardiopulmonary, neurologic, or cardiovascular status) 3. Patients with IPMN that has been subjected to FNA or biopsy prior to the LINFU procedure 4. Patients with pancreatic cystic neoplasms other than IPMN i.e. mucinous cystic neoplasms, serous cystic neoplasms and other rare cystic lesions 5. Pregnant females will be excluded 6. Patient that is unable to provide informed consent 7. Patient with known allergy to the microbubble contrast agent or secretin Study Design Overview:

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Conditions

The condition(s) this trial relates to.

malignant pancreatic neoplasm Pancreatic Cyst Pancreatic Intraductal Neoplasms pancreatic intraductal papillary-mucinous neoplasm pancreatic neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ipmn, pancreatic Pancreas cancer Pancreatic cyst

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Manhattan Endoscopy Center

    New York, New York, 10007, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.