PET/CT Scans Using the Tracer 11C-Csar, a Bile Acid Analog, to Depict and Visualize Changes in the Hepatobiliary System in Patients With Primary Biliary Cholangitis Before and After Treatment.

NCT06604923 | Active Not Recruiting DMC

• 2 other identifiers: Csar_PBC1-10-72-64-24
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose The primary purpose is to use an imaging diagnostic method to examine how the medication for primary biliary cholangitis (PBC) works. This will be studied using a radioactive tracer that behaves like human bile and can be observed with a PET/CT scanner. The aim is to gain insight into the disease mechanisms and how the medication affects them. The standard treatment for PBC is ursodeoxycholic acid, also known as Ursochol, which stimulates bile flow. If treatment with Ursochol is insufficient, bezafibrate can be added. The effectiveness of treatment is currently monitored through blood tests, which do not necessarily reflect the severity of the liver disease. However, this can be assessed using advanced PET/CT scans with a radioactive tracer, 11C-CSAR, which quickly clears from the body. The purpose of this study is to use the method to show how 11C-CSAR moves through the liver and bile ducts in PBC patients before and after treatment with either Ursochol or a combination of Ursochol and bezafibrate. We aim to:

• Observe how the disease affects the liver\'s handling of bile salts and how this changes with medication.
• Determine the excretion kinetics of 11C-CSAR, including specific rate constants.
• Assess changes in liver blood flow before and after treatment.
• Compare routine blood tests with 11C-CSAR PET/CT findings to evaluate how well blood tests reflect actual liver involvement. Study Plan The scientific study involves two examination days. Both days follow the same procedure. Participants must arrive fasting on the examination day. An intravenous catheter will be placed in each arm, a catheter in a wrist vessel, and a liver vein catheter. The liver vein catheter will be inserted by a trained liver doctor through a small sheath in a neck vein, guided by ultrasound, and the final placement will be confirmed with fluoroscopy. The tracer 11C-CSAR and the dye indocyanine green (ICG) will be administered through the intravenous lines. ICG will be given as a constant infusion 90 minutes before the scan to distribute in the tissue. The tracer will be injected just before the scan. Blood samples will be taken from the liver catheter and wrist catheter during the scan, which lasts approximately 45 minutes. After the scan, the catheters will be removed, and the participant can leave shortly afterward. About 250-300 ml of blood will be drawn during the scan, which will have no significant impact on participants. The entire process is expected to take about four hours. Study Participants Our goal is to include 20 newly diagnosed PBC patients and 10 patients who do not respond to standard treatment and are about to begin bezafibrate. Some participants may complete both parts of the study. If newly diagnosed patients do not respond sufficiently to Ursochol and need to start bezafibrate while the study is ongoing, they may participate both before and after starting Ursochol and bezafibrate.

Conditions

Primary Biliary Cholangitis (PBC); Cirrhosis; Cholestasis; Ursodeoxycholic Acid; Bezafibrate

Outcome Measures

Primary Outcomes (1)

• The aim of this study is to apply the 11C-CSAR PET/CT method to quantify hepatobiliary secretion kinetics of 11C-Csar in patients with primary biliary cholangitis before and after treatment

  \- Changes in the hepatobiliary excretion kinetics of 11C-CSar after treatment with 1) UDCA or 2) UDCA and bezafibrate

  through study completion, an average of 2 years

Secondary Outcomes (2)

• Aim The aim of this study is to apply the 11C-CSAR PET/CT method to quantify hepatobiliary secretion kinetics of 11C-Csar in patients with primary biliary cholangitis before and after treatment

  Through study completion, an average of 2 years

• The aim of this study is to apply the 11C-CSAR PET/CT method to quantify hepatobiliary secretion kinetics of 11C-Csar in patients with primary biliary cholangitis before and after treatment

  Through study completion, an average of 2 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with primary biliary cholangitis from The Central Region in Denmark,

You may qualify if:

• \- A clinical diagnosis of PBC as defined by guidelines (3).
• Age ≥ 18.
• For fertile female participants: A negative urinary pregnancy test performed on the day of the scan.
• Treatment-naïve patients:
• DiagnosisofPBCwithin\<1year
• NopriortreatmentforPBC(UDCA,bezafibrate)
• Non-responders to UDCA:
• Insufficient treatment response to UDCA defined by guidelines (ALP\>160U/I)

You may not qualify if:

• \- Pregnancy
• Claustrophobia or the inability to remain still during a 45-minute scan.
• Coagulation deficiency that does not allow hepatic vein catheter (relative).

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

The Department of Hepatology and Gastroeneterology Aarhus University Hospital.

Aarhus, 8210, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples in a biobank

MeSH Terms

Conditions

Liver Cirrhosis, Biliary; Fibrosis; Cholestasis

Condition Hierarchy (Ancestors)

Cholestasis, Intrahepatic; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases; Liver Diseases; Liver Cirrhosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2024
• First Posted: September 20, 2024
• Study Start: September 4, 2024
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: September 20, 2024

Record last verified: 2024-09

Locations

DK (1)