Cholestasis, Primary Biliary Cirrhosis, Primary Sclerosing Cholangitis
Conditions
Brief summary
We wish to develop a protocol for PET/CT examination of humans using the bile acid tracer 11C-cholylsarcosine. This is done by a series of PET/CT examinations of healthy humans and patients with cholestatic disorders.
Detailed description
The purpose of the study is the development of PET/CT protocols using 11C-CSar for human use. PET/CT methods developed in the pig studies are translated to studies in healthy humans and patients with cholestatic disorders. Dynamic PET/CT scans of the liver and biliary system are combined with measurements of tracer concentrations in a radial artery and a liver vein and measurements of hepatic blood flow by intravenous infusion of indocyanine green (ICG)/Ficks principle. Kinetic parameters from PET/CT measurements and invasive measurements are compared for validation of the PET estimated parameters and refinement of the PET modeling, if required.
Interventions
DRUG11C-CSar
PET/CT recording with bile acid tracer 11C-cholylsarcosine used to evaluate the transport of bile acids.
DRUGICG
Infusion of indocyanine green prior and during the PET/CT scanning with the bile tracer 11C-CSar.
Sponsors
University of Aarhus
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Patients with cholestatic disorders and healthy subjects
Exclusion criteria
* Body weight above 110 kg (catheterization problematic). * Diabetes * Pregnant or breast feeding women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants in Whom we Could Quantify Hepatic Transport of 11C-CSar | All measurements are performed in one day. |
Countries
Denmark
Participant flow
Recruitment details
10 healthy subjects were recruided after they responded to an advertisement in the local newspaper. 12 patients with varying degree of cholestasis and different underlying diseases were recruided from the Department of hepatology and gastroenterology Aarhus University Hospital.
Participants by arm
| Arm | Count |
|---|---|
| ICG's Effect on 11C-CSar Transport Examine the effect of indocyanine green (ICG) on the rate constants for the hepatic transport of 11C-CSar. Compare the observed kinetics in11C-CSar PET/CT recordings done with and without simultanous infusion of ICG. | 6 |
| Bolus vs. Constant Infusion Determine wether bolus or constant infusion of 11C-CSar is optimal for the PET/CT scanning. Two 11C-CSar PET/CT recordings were performed in each subject. One with bolus infusion and one with constant infusion. | 16 |
| Total | 22 |
Baseline characteristics
| Characteristic | Total | ICG's Effect on 11C-CSar Transport | Bolus vs. Constant Infusion |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 1 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 5 Participants | 12 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 22 Participants | 6 Participants | 16 Participants |
| Sex: Female, Male Female | 14 Participants | 3 Participants | 11 Participants |
| Sex: Female, Male Male | 8 Participants | 3 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 6 | 0 / 16 |
| serious Total, serious adverse events | 0 / 6 | 0 / 16 |
Outcome results
Primary
Percentage of Participants in Whom we Could Quantify Hepatic Transport of 11C-CSar
Time frame: All measurements are performed in one day.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ICG Infusion | Percentage of Participants in Whom we Could Quantify Hepatic Transport of 11C-CSar | 100 percentage of participants |
| Infusion Method | Percentage of Participants in Whom we Could Quantify Hepatic Transport of 11C-CSar | 100 percentage of participants |