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 @ 2:03 PM
Ignite Modification Date:
2025-12-24 @ 2:03 PM
NCT ID:
NCT06610695
Eligibility Criteria:
Inclusion Criteria:
* Criteria for inclusion of healthy individuals
* No prior or current history of liver diseases
* No medication that interferes with the hepatobiliary system
* Age above 18
* A signed consent must be present on the day of the 11-CSAR PET/CT scan.
* A negative pregnancy test performed on the day of the scan.
Exclusion Criteria:
* Prior cholecystectomy
* Pregnancy
* Assessed ineligibility by a medical doctor based on blood parameters measured at inclusion if these are abnormal.
* Claustrophobia or the inability to remain still during a 45-minute scan.
Criteria for inclusion of patients with cholestasis
* Cholestasis at the time of inclusion, measured by elevated AP, bilirubin, or both.
* Ultrasound sonography which ruled out mechanical obstruction.
* Age above 18
* A signed consent must be present on the day of the 11C-CSAR PET/CT scan.
* A negative pregnancy test performed on the day of the scan. Criteria for exclusion of patients with cholestasis
* Pregnancy
* Claustrophobia or the inability to remain still during a 45-minute scan.
* Coagulation deficiency that does not allow hepatic vein catheter (relative).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06610695
Study Brief:
Protocol Section:
NCT06610695