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NCT06276764Enrolling by invitation

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

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)

Source: ClinicalTrials.gov · Last updated 6 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Enrolling by invitation
Study type
Observational
Enrollment
500 (estimated)
First submitted
18 Feb 2024
Start date
15 Oct 2024
Primary completion date
30 Sept 2034
Lead sponsor
Adenocyte, LLC
NCT number
NCT06276764

What you commit to

  • Study type: Observational
  • Planned participants: 500
  • From 15 Oct 2024 to the primary completion date, 30 Sept 2034
  • 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.

Prior treatment

  • Patients with IPMN that has been subjected to FNA or biopsy prior to the LINFU procedure

Other illness

  • Patient with known allergy to the microbubble contrast agent or secretin
    • Study Design Overview:

Age

  • Patient under the age of 18 and over the age 90

Other

  • 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 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

Who the study is looking for

  • 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.

Age in the registry: 18 years to 90 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Manhattan Endoscopy Center
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.