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Clinical Trials in the USA / NCT04793633
Enrolling by invitation Observational

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

NCT04793633 · tracked via the Priya Life Science USA tracker
Sponsor
Adenocyte, LLC
Phase
Observational
Started
2024-01-31
Last updated
2024-03-12

Condition(s) studied

Pancreatic Ductal Adenocarcinoma

Investigational drug(s) / intervention(s)

LINFU™ Technique

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

Study summary

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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
90 Years
Healthy volunteers
No
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, who in the opinion of the Investigator, are at elevated risk of developing a pancreatic malignancy because they have known risk factors for PDAC or signs or symptoms of PDAC 3. High risk asymptomatic patients being screened for PDAC 4. Patients with clinical signs or symptoms of PDAC including abnormal imaging and who are scheduled for EUS- FNA, MRI/MRCP, ERCP, or CT will be enrolled 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/EUS/ERCP 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 undergoing EUS or ERCP for a suspected bile duct cancer arising from the intrahepatic or extrahepatic biliary epithelium 4. Pregnant females will be excluded 5. Patient that is unable to provide informed consent 6. Patient with known allergy to the microbubble contrast agent or secretin

Primary outcome measure(s)

  • The number of pancreatic ductal adenocarcinomas and their noninvasive precursor — 5 years
    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- FNA, MRI/MRCP, ERCP, CT and CEUS.

Trial sites (1)

FacilityCityRegionStatus
Sarasota Memorial HealthCare System Sarasota Florida

More Adenocyte, LLC trials in the USA

The LINFU® U.S. Registry for the Detection of Asymptomatic Pancreatic Ductal Adenocarcinoma Enrolling by invitation
The LINFU® U.S. Registry in Patients With IPMN (Intraductal Papillary Mucinous Neoplasm of the Pancreas) Enrolling by invitation

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Safety of RAD301 in Healthy Human Volunteers and Patients With Pancreatic Cancer or Other Solid Tumors Active, not recruiting
MOONRAY-01, A Study of LY3962673 in Participants With KRAS G12D-Mutant Solid Tumors Active, not recruiting
Phase I Study of [177Lu]Lu-DFC413 in Patients With Solid Tumors Recruiting
A Study to Learn About the Study Medicine Called PF-08098488 in People With Advanced Solid Tumors. Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04793633 on ClinicalTrials.gov ↗ ← All trials in the USA