The LINFU® U.S. Registry in Patients With Clinical Signs and/or Symptoms of Disease

ConditionsPancreatic Cancer Jaundice Abdominal Neoplasm

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18-90

SponsorAdenocyte, LLC

About this trial

Evaluate LINFU® in patients who exhibit signs or symptoms (i.e. jaundice, abdominal pain, weight loss, nausea and vomiting etc.) suggestive of pancreatic cancer (PDAC) or have evidence of imaging studies suggestive of PDAC.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Both males and females will be enrolled and must be at least 18 years of age and under age of 90

Patients, who in the opinion of the Investigator, require biopsy to rule out PDAC because they display at least one of the following or both: a) clinical symptoms of PDAC including jaundice, nausea and vomiting, weight loss, abdominal pain, bloating or the feeling of fullness, itchy skin, lower back pain, light-colored, greasy stools, sudden onset type 2 diabetes, etc. b) one or more imaging studies suggestive of PDAC

All patients must undergo contemporaneous imaging, either within 90 days before the LINFU® procedure or within 30 days after the procedure, with one or more of the following: EUS± FNA, MRI/MRCP, ERCP, CT or CEUS.

Institutional Review Board (IRB)-approved consent must be signed by patients to participate in this study.

Disqualifiers

Patient under the age of 18 and over the age 90

Contraindications to LINFU®/EUS/ERCP 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 undergoing EUS or ERCP for a suspected bile duct cancer arising from the intrahepatic or extrahepatic biliary epithelium

Patients who are already known to have PDAC by cytologic or histologic evidence

Trial population

High risk patients with either clinical symptoms or imaging abnormalities or both, being evaluated for PDAC.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

LINFU® (Low Intensity Non-Focused Ultrasound excitation of the pancreas)
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.

Treatment groups

1,000 Participants

are divided into 1 treatment group

Group A: Patients at increased risk for developing pancreatic cancer1 intervention

Trial outcomes

Primary outcomes

The number of pancreatic ductal adenocarcinomas identified only with LINFU® will be compared to standard screening methods

The total number of pancreatic ductal adenocarcinomas identified with LINFU® by analysis of pancreatic fluid will be compared to the number of these lesions identified with current screening tests, including endoscopic ultrasound ± fine needle aspiration (EUS± FNA),magnetic resonance imaging / magnetic resonance cholangiopancreatography (MRI/MRCP), endoscopic retrograde cholangiopancreatography (ERCP),computed tomography (CT) or contrast-enhanced ultrasound (CEUS).

Time frame

5 years

Secondary outcomes

The change in size of pancreatic ductal adenocarcinomas identified only with LINFU® will be determined

Patients with pancreatic ductal adenocarcinomas identified only with LINFU® and not detected with other diagnostic tests will be monitored long- term (5 years) by EUS- FNA, MRI/MRCP, ERCP, CT and CEUS to assess whether these tumors increase in size (measured in mm) and to determine how many require medical or surgical intervention.

Time frame

5 years

Determine the number of patients with pancreatic ductal adenocarcinoma identified only with LINFU® that require medical or surgical intervention

Patients with pancreatic ductal adenocarcinomas identified only with LINFU® and not detected with other diagnostic tests will be monitored long- term (5 years) by EUS- FNA, MRI/MRCP, ERCP, CT and CEUS to assess whether these tumors increase and how many require medical or surgical intervention.

Time frame

5 years

Other outcomes

Yearly survival rate of patients with pancreatic ductal adenocarcinomas identified only with LINFU®

Patients will be followed by EUS- FNA, MRI/MRCP, ERCP, CT and CEUS and yearly survival rates of patients with pancreatic ductal adenocarcinomas identified only with LINFU® and not detected with other diagnostic tests will be recorded.

Time frame

5 years

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Adenocyte, LLC

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: