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Trial record 76 of 92 for:    Primary Sclerosing Cholangitis

Biliary Excretion of Conjugated Bile Acids in Humans Measured by 11C-cholylsarcosine PET/CT

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ClinicalTrials.gov Identifier: NCT01879735
Recruitment Status : Completed
First Posted : June 18, 2013
Results First Posted : February 23, 2015
Last Update Posted : February 23, 2015
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Conditions Cholestasis
Primary Sclerosing Cholangitis
Primary Biliary Cirrhosis
Interventions Drug: 11C-CSar
Drug: ICG
Enrollment 22
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.

Pre-assignment Details  
Arm/Group Title ICG Infusion Bolus and Constant Infusion of 11C-CSar
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 6 16
Completed 6 16
Not Completed 0 0
Arm/Group Title ICG's Effect on 11C-CSar Transport Bolus vs. Constant Infusion Total
Hide Arm/Group Description 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 6 16 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 16 participants 22 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
  83.3%
12
  75.0%
17
  77.3%
>=65 years
1
  16.7%
4
  25.0%
5
  22.7%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 16 participants 22 participants
Female
3
  50.0%
11
  68.8%
14
  63.6%
Male
3
  50.0%
5
  31.3%
8
  36.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 16 participants 22 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
6
 100.0%
16
 100.0%
22
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title Percentage of Participants in Whom we Could Quantify Hepatic Transport of 11C-CSar
Hide Description [Not Specified]
Time Frame All measurements are performed in one day.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title ICG Infusion Infusion Method
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 6 16
Measure Type: Number
Unit of Measure: percentage of participants
100 100
Time Frame Subjects were observed during the PET/CT recordings and for 2 hours after the final PET/CT-recording.
Adverse Event Reporting Description 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.
 
Arm/Group Title ICG's Effect on 11C-CSar Transport Bolus vs. Constant Infusion
Hide Arm/Group Description 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. 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.
All-Cause Mortality
ICG's Effect on 11C-CSar Transport Bolus vs. Constant Infusion
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
ICG's Effect on 11C-CSar Transport Bolus vs. Constant Infusion
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/16 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
ICG's Effect on 11C-CSar Transport Bolus vs. Constant Infusion
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/16 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Susanne Keiding M.D., Associate professor, D.Sc.
Organization: Dept. of Nuclear Medicine & PET-center, Dept. of Hepatology and Gastroenterolgy. Aarhus University Hospital
Phone: +45 7846 3031
EMail: susanne@pet.auh.dk
Layout table for additonal information
Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01879735     History of Changes
Other Study ID Numbers: C-CSar humane 244
First Submitted: June 11, 2013
First Posted: June 18, 2013
Results First Submitted: January 19, 2015
Results First Posted: February 23, 2015
Last Update Posted: February 23, 2015