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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICG's effect on 11C-CSar transport | Experimental | Examine the effect of ICG on the kinetics of the hepatic transport of 11C-CSar. If no effect is seen on the kinetics, ICG will be used during the "infusion method" experiments. |
|
| Infusion method | Experimental | Determine wether bolus or constant infusion of 11C-CSar is optimal for the PET/CT scanning. If ICG does not affect the kinetics of 11C-CSar it will be used during these experiments to calculate hepatic blood flow. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 11C-CSar | Drug | PET/CT recording with bile acid tracer 11C-cholylsarcosine used to evaluate the transport of bile acids. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants in Whom we Could Quantify Hepatic Transport of 11C-CSar | All measurements are performed in one day. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Susanne Keiding, M.D. D.Sc. | Aarhus University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nuclear medicine and PET-center | Aarhus | Aarhus C | 8000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28249726 | Derived | Orntoft NW, Munk OL, Frisch K, Ott P, Keiding S, Sorensen M. Hepatobiliary transport kinetics of the conjugated bile acid tracer 11C-CSar quantified in healthy humans and patients by positron emission tomography. J Hepatol. 2017 Aug;67(2):321-327. doi: 10.1016/j.jhep.2017.02.023. Epub 2017 Feb 27. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | ICG Infusion | Examine the effect of indocyanine green (ICG) on the hepatic transport of 11C-CSar. Compare the observed kinetics in11C-CSar PET/CT recordings done with and without simultanous infusion of ICG. |
| FG001 | Bolus and Constant Infusion of 11C-CSar | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Bolus vs. Constant Infusion |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Participants in Whom we Could Quantify Hepatic Transport of 11C-CSar | Posted | Number | percentage of participants | All measurements are performed in one day. |
|
Subjects were observed during the PET/CT recordings and for 2 hours after the final PET/CT-recording.
A minor physical examination with blood pressure and puls was performed by a doctor or nurse every 30 minutes for at lest 2 hours after the last PET/CT recording.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ICG's Effect on 11C-CSar Transport | Examine the effect of indocyanine green (ICG) on the hepatic transport of 11C-CSar. Compare the observed kinetics in11C-CSar PET/CT recordings done with and without simultanous infusion of ICG. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Susanne Keiding M.D., Associate professor, D.Sc. | Dept. of Nuclear Medicine & PET-center, Dept. of Hepatology and Gastroenterolgy. Aarhus University Hospital | +45 7846 3031 | susanne@pet.auh.dk |
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| ID | Term |
|---|---|
| D002779 | Cholestasis |
| D015209 | Cholangitis, Sclerosing |
| D008105 | Liver Cirrhosis, Biliary |
| ID | Term |
|---|---|
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D002761 | Cholangitis |
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| ID | Term |
|---|---|
| C061997 | cholylsarcosine |
| D007208 | Indocyanine Green |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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|
| ICG | Drug | Infusion of indocyanine green prior and during the PET/CT scanning with the bile tracer 11C-CSar. |
|
|
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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | 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. | 0 | 16 | 0 | 16 |
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| D002780 |
| Cholestasis, Intrahepatic |
| D008107 | Liver Diseases |
| D008103 | Liver Cirrhosis |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |