Evaluating LINFU™: A Noninvasive Method for Collecting Pancreatic Cells for the Early Detection of Pancreatic Cancer

Part of paid clinical trials in Sarasota, Florida.

Sponsor
Adenocyte, LLC
Study ID
NCT04793633
Status
Enrolling By Invitation

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • LINFU™ Technique — COMBINATION_PRODUCT
    Non-focused ultrasound excitation of the pancreas with IV Lumason and IV secretin injected during the ultrasound procedure.

Study Details

Adenocyte has developed LINFU®, (Low Intensity Non-Focused Ultrasound excitation of the pancreas) as a method of identifying early, asymptomatic pancreatic cancer and its noninvasive precancerous lesions. The test involves ultrasound and an analysis of pancreatic juice. A neural network-based computer-assisted system may be utilized to enhance the analysis. Patients enrolled are being screened for pancreatic cancer because they have known risk factors (i.e. smoking, diabetes, chronic pancreatitis, family history of pancreatic cancer, or certain genetic syndromes).

Key Dates

Start date
Jan 31, 2024
Status verified
Mar 2024
Primary completion
Dec 30, 2030
Completion
Dec 30, 2030

Study Design

Enrollment
500 participants (estimated)

Arms

  • Arm: Patients at increased risk for developing pancreatic cancer
    Patients being screened for pancreatic cancer because they have known risk factors (i.e. smoking, diabetes, chronic pancreatitis, family history of pancreatic cancer, or certain genetic syndromes) or have signs or symptoms of disease and are undergoing other imaging diagnostic tests to determine if they have pancreatic cancer

Primary Outcome Measure

The number of pancreatic ductal adenocarcinomas and their noninvasive precursor [ Time Frame: 5 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
Sarasota Memorial HealthCare SystemSarasotaFlorida34239-

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