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

Part of paid clinical trials in New York, New York.

Sponsor
Adenocyte, LLC
Study ID
NCT06276764
Status
Enrolling By Invitation

Conditions

  • IPMN, Pancreatic
  • Pancreas Cancer
  • Pancreatic Cyst

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Accepted

Interventions

  • 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 Details

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.

Key Dates

Start date
Oct 15, 2024
Status verified
Mar 2025
Primary completion
Sep 30, 2034
Completion
Dec 1, 2034

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: Patients with a documented history of IPMN
    Patients with a documented history of IPMN by any imaging method will undergo the LINFU® procedure.

Primary Outcome Measure

The number of pancreatic ductal adenocarcinomas or their precursor lesions, dysplasia, identified only with LINFU® will be compared to standard screening methods [ Time Frame: 5 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Manhattan Endoscopy CenterNew YorkNew York10007-

Find similar trials in New York, NY

By research site
Manhattan Endoscopy Center· New York, NY

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