Determination of radiation dose for the bile acid tracer 11C-CSar in humans

Status

Active, not recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004031-20-DK

Enrollment

Registered

2016-10-06

Start date

2017-02-20

Completion date

Unknown

Last updated

2020-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with cholestatic liver disease and healthy humans MedDRA version: 19.0 Level: SOC Classification code 10022891 Term: Investigations System Organ Class: 10022891 - Investigations

Interventions

Product Name: 11C-cholylsarcosine Product Code: V09DX Pharmaceutical Form: Solution for injection/infusion INN or Proposed INN: 11C-cholylsarcosine CAS Number: 93790-70-6 Concentration unit: MBq/ml me

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: healthy subjects and patients with cholestatic liver disease Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 5 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 3

Exclusion criteria

Exclusion criteria: Body weight above 100 kg ; pregnant or breast feeding woman.

Design outcomes

Primary

Measure	Time frame
Main Objective: The objective of the trial is to define biodistribution of 11C-CSar in the human body in healthy subjects and patients with cholestatic liver disease and to estimate equivalent dose exposure.;Secondary Objective: not applicable;Primary end point(s): 1. biodistribution of 11C-CSar in the human body in healthy subjects and patients with cholestatic liver disease 2. equivalent radiation dose.;Timepoint(s) of evaluation of this end point: Data from every subject studied are analyzed immediately after the scanning and all data are analyzed collectively after inclusion of the last subject.	—

Measure

Time frame

Main Objective: The objective of the trial is to define biodistribution of 11C-CSar in the human body in healthy subjects and patients with cholestatic liver disease and to estimate equivalent dose exposure.;Secondary Objective: not applicable;Primary end point(s): 1. biodistribution of 11C-CSar in the human body in healthy subjects and patients with cholestatic liver disease 2. equivalent radiation dose.;Timepoint(s) of evaluation of this end point: Data from every subject studied are analyzed immediately after the scanning and all data are analyzed collectively after inclusion of the last subject.

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Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: June 2017	—

Countries

Denmark

Contacts

Public Contactsenior lecturer

Aarhus University Hospital

susakeid@rm.dk4578463031

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026