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:
2025-12-24 @ 7:17 PM
Ignite Modification Date:
2025-12-24 @ 7:17 PM
NCT ID:
NCT06276803
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, do not exhibit any 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.
3. Patients, who in the opinion of the Investigator, do not have an abnormal imaging study suggestive of PDAC
4. Patients, who in the opinion of the Investigator, should not be ordinarily screened for PDAC because they do not have risk factors including chronic pancreatitis, family history of PDAC, or genetic cancer syndromes which increase the risk of developing PDAC
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, who in the opinion of the Investigator, are at risk of PDAC because they exhibit any of the following: clinical symptoms of PDAC, imaging abnormalities suggestive of PDAC, genetic syndromes which increase the risk of PDAC, a first degree relative with a history of pancreatic cancer, excessive exposure to dry-cleaning and metalworking chemicals
4. Patients who consume alcohol (greater than 3 drinks/day \>1 year or \>15g/day for \>1 year will be excluded
5. Patient with any history of adult-onset diabetes will be excluded
6. Patients who are obese (body mass index \[BMI\] of 30 or more) will be excluded
7. Patients who have consumed tobacco in the past for greater than 1 year or current smokers will be excluded.
8. Patients with a history of any pancreatic disease, including chronic pancreatitis, or any pancreatic imaging abnormality including intraductal papillary mucinous neoplasm of the pancreas (IPMN)
9. Patients with baseline lipase levels that are abnormal
10. Pregnant females will be excluded
11. Patient that is unable to provide informed consent
12. Patient with known allergy to the microbubble contrast agent or secretin
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT06276803
Study Brief:
Protocol Section:
NCT06276803