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 @ 11:24 PM
Ignite Modification Date:
2025-12-24 @ 11:24 PM
NCT ID:
NCT00621556
Eligibility Criteria:
Inclusion Criteria:
* Males and females older than 18 years of age
* Is clinically indicated for MRCP of the pancreas based on prior imaging features suggestive or suspicious of IPMN (eg. Cystic lesion in the pancreas along the duct, ductal dilatation)
* Scheduled for MRCP and therapeutic or diagnostic ERCP or surgery for the IPMN
* Has been fully informed and has personally signed and dated the Written Informed Consent and Health Insurance Portability Accountability Act (HIPAA) provisions
* Is a male, or is a female not of childbearing potential, or is a female of childbearing potential who is using effective contraception and has a negative serum pregnancy test on the same day, but prior to, study drug administration
* Is able and willing to complete all study procedures specified in the protocol
Exclusion Criteria:
* Presence of a pancreatic stent
* History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease which, in the opinion of the investigator, precludes study participation
* History of sensitivity to any of the ingredients in the study drug
* Pregnancy
* Any contraindication to MRI procedure, including but not limited to implanted metal devices (e.g., pacemaker, aneurysm clips, cochlear implants)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT00621556
Study Brief:
Protocol Section:
NCT00621556