Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-25 @ 3:01 AM
NCT ID:
NCT04793633
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT04793633
Study Brief:
Protocol Section:
NCT04793633