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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06276764
Other study ID # Adenocyte 103
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date June 15, 2024
Est. completion date May 1, 2034

Study information

Verified date May 2024
Source Adenocyte, LLC
Contact Stephanie Lazarus
Phone 9142632030
Email slazarus@adenocyte.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

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.


Description:

Adenocyte has developed a proprietary pancreatic cancer detection method, LINFU®, (Low Intensity Non-Focused Ultrasound excitation of the pancreas) that increases the sensitivity of pancreatic juice cytology. LINFU® excitation of circulating microbubbles increases the exfoliation of pancreatic ductal cells. The sensitivity of cytological examination of the pancreatic fluid obtained by LINFU® can also be potentially enhanced by neural network-based computer-assisted analysis. 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) which are not identified with current diagnostic tests. In addition, patients identified with PDAC or precursor lesions only with LINFU® and not detected with other diagnostic tests will be followed long term to determine the progression rate of these tumors and whether LINFU® results in earlier intervention, treatment and improvement in patient outcomes


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 500
Est. completion date May 1, 2034
Est. primary completion date March 30, 2034
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 90 Years
Eligibility 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 with a documented history of IPMN by any imaging method. 3. 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 4. Patients undergoing EUS-FNA may be enrolled but the FNA must be performed after the LINFU® procedure 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® 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 with IPMN that has been subjected to FNA or biopsy prior to the LINFU procedure 4. Patients with pancreatic cystic neoplasms other than IPMN i.e. mucinous cystic neoplasms, serous cystic neoplasms and other rare cystic lesions 5. Pregnant females will be excluded 6. Patient that is unable to provide informed consent 7. Patient with known allergy to the microbubble contrast agent or secretin Study Design Overview:

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
LINFU®
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.
Standard imaging tests
EUS, CH-EUS, CEUS, MRI/MRCP, PET/CT, CT

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Adenocyte, LLC

Outcome

Type Measure Description Time frame Safety issue
Other Yearly survival rate of patients with early pancreatic ductal adenocarcinomas or their noninvasive precursor lesions identified only with LINFU® Patients will be followed by EUS, CH-EUS, CEUS, MRI/MRCP, PET/CT, CT and yearly survival rates of patients with early pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified only with LINFU® and not detected with other diagnostic tests will be recorded. 5 years
Primary The number of pancreatic ductal adenocarcinomas or their precursor lesions, dysplasia, identified only with LINFU® will be compared to standard screening methods 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, CH-EUS, CEUS, MRI/MRCP, PET/CT, CT 5 years
Secondary The change in size of pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified only with LINFU® will be determined over a 5 year period Patients with early pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified only with LINFU® and not detected with other diagnostic tests will be monitored long- term (5 years) by EUS, CH-EUS, CEUS, MRI/MRCP, PET/CT, CT to assess whether these tumors increase in size (measured in mm) and to determine how many require medical or surgical intervention. 5 years
Secondary Determine the number of patients with early pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified only with LINFU® that require medical or surgical intervention. Patients with early pancreatic ductal adenocarcinomas and their noninvasive precursor lesions identified only with LINFU® and not detected with other diagnostic tests will be monitored long- term (5 years) by EUS, CH-EUS, CEUS, MRI/MRCP, PET/CT, CT to assess whether these tumors increase how many require medical or surgical intervention. 5 years
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