IPMN, PancreaticNCT06276764

The LINFU® U.S. Registry in Patients With IPMN (Intraductal Papillary Mucinous Neoplasm of the Pancreas)

An observational study of IPMN, Pancreatic and Pancreas Cancer, run by Adenocyte, LLC at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 to 90 yearsHealthy volunteers can take part
Conditions the study is for: IPMN, Pancreatic, Pancreas Cancer, Pancreatic Cyst
What is being tested?: LINFU®
Type of treatment: Injection or infusion
How many people: 500 participants
Where: 1 siteUnited States
Study dates: 15 Oct 2024to 1 Dec 2034
How long will I take part?: 5 Years
Phase: Observational

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 to 90 years
All sexes
Healthy volunteers accepted
Adult, Older adult

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

Who may be able to join

Both males and females will be enrolled and must be at least 18 years of age and under age of 90
Patients with a documented history of IPMN by any imaging method.
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
Patients undergoing EUS-FNA may be enrolled but the FNA must be performed after the LINFU® procedure
Institutional Review Board (IRB)-approved consent must be signed by patients to participate in this study.

Who cannot join

Patient under the age of 18 and over the age 90
Contraindications to LINFU® as determined by study investigators:
Patient with uncorrectable coagulopathy
Patient that cannot undergo anesthesia due to cardiopulmonary contraindication as deemed by the anesthesiologist
Unstable medically (cardiopulmonary, neurologic, or cardiovascular status)
Patients with IPMN that has been subjected to FNA or biopsy prior to the LINFU procedure

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Patients with pancreatic cystic neoplasms other than IPMN i.e. mucinous cystic neoplasms, serous cystic neoplasms and other rare cystic lesions
Pregnant females will be excluded
Patient that is unable to provide informed consent
Patient with known allergy to the microbubble contrast agent or secretin
Study Design Overview:

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

Manhattan Endoscopy Center
New York, New York, 10007

Other trials in United States

About this study

Official title: The LINFU® U.S. Registry for the Detection of Dysplasia and Pancreatic Ductal Adenocarcinoma (PDAC) in Patients With IPMN (Intraductal Papillary Mucinous Neoplasm of the Pancreas)

In this study, LINFU® will be evaluated in patients who have been identified with IPMN to determine if it can be used to help identify early, pancreatic ductal adenocarcinoma and its noninvasive precursor lesions (dysplasia). The study will also help determine if LINFU® results in earlier intervention, treatment and improvement in patient outcomes.

Read the detailed description

Adenocyte has developed a proprietary pancreatic cancer detection method, LINFU®, (Low Intensity Non-Focused Ultrasound excitation of the pancreas) that increases the sensitivity of pancreatic juice cytology. LINFU® excitation of circulating microbubbles increases the exfoliation of pancreatic ductal cells. The sensitivity of cytological examination of the pancreatic fluid obtained by LINFU® can also be potentially enhanced by neural network-based computer-assisted analysis.

In this study, LINFU® will be evaluated in patients who have been identified with IPMN to determine if it can be used to help identify early, pancreatic ductal adenocarcinoma and its noninvasive precursor lesions (dysplasia) which are not identified with current diagnostic tests. In addition, patients identified with PDAC or precursor lesions only with LINFU® and not detected with other diagnostic tests will be followed long term to determine the progression rate of these tumors and whether LINFU® results in earlier intervention, treatment and improvement in patient outcomes

Conditions: IPMN, Pancreatic, Pancreas Cancer, Pancreatic Cyst
Being tested: LINFU®
Medical subject headings: Pancreatic Intraductal Neoplasms, Pancreatic Neoplasms, Pancreatic Cyst

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LINFU®Diagnostic test
Patients will undergo low intensity non-focused ultrasound excitation of the pancreas for a total of 15 minutes. A contrast agent will be administered IV at five minute intervals. The patient will then receive a dose of secretin and the the patient's pancreatic juice will then be collected for a total of 15 minutes.

Study groups in NCT06276764
Study group	Role	What they receive
Patients with a documented history of IPMN		Patients with a documented history of IPMN by any imaging method will undergo the LINFU® procedure. Receives: Diagnostic Test: LINFU®

What is being measured

The primary outcome is the main question the study is designed to answer.

The number of pancreatic ductal adenocarcinomas or their precursor lesions, dysplasia, identified only with LINFU® will be compared to standard screening methods
The total number of asymptomatic pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified with LINFU® by analysis of pancreatic fluid will be compared to the number of these lesions identified with current screening tests, including EUS, CH-EUS, CEUS, MRI/MRCP, PET/CT, CT
Measured: 5 years

Secondary outcomes (2)

The change in size of pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified only with LINFU® will be determined over a 5 year period
Patients with early pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified only with LINFU® and not detected with other diagnostic tests will be monitored long- term (5 years) by EUS, CH-EUS, CEUS, MRI/MRCP, PET/CT, CT to assess whether these tumors increase in size (measured in mm) and to determine how many require medical or surgical intervention.
Measured: 5 years
Determine the number of patients with early pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified only with LINFU® that require medical or surgical intervention.
Patients with early pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified only with LINFU® and not detected with other diagnostic tests will be monitored long- term (5 years) by EUS, CH-EUS, CEUS, MRI/MRCP, PET/CT, CT to assess whether these tumors increase how many require medical or surgical intervention.
Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Oct 20241 Dec 2034

First posted26 Feb 2024
Study start15 Oct 2024
Primary completion30 Sep 2034 (estimated)
Study completion1 Dec 2034 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for IPMN, PancreaticStudies 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 500 participants (estimated)
Target duration: 5 Years

IDs, dates and publications

ClinicalTrials.gov ID: NCT06276764
Sponsor's protocol ID: Adenocyte 103
Status last verified: Aug 2026
First submitted: 18 Feb 2024
Last updated: 6 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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