CT scan - Clinical trial details 

The Role of Gadoxetate (Eovist) Enhanced CT in Evaluating Cholangiocarcinoma

Recruitment status:
Recruiting
Primary Sponsor:
University of Alabama at Birmingham
Recruitment countries:
Health condition studied:
Cholangiocarcinoma
URL:
Link to the clinical trial website

About the trial

Interventions:
Radiation: CT scan
Key inclusion and exclusion criteria:

  • Inclusion Criteria:

    1. Subjects will be adult (age 19 or older) with suspected cholangiocarcinoma of the
    liver.

    2. Subject must be able to provide a written informed consent.

    3. Subject will be scheduled for gadoxetate contrast enhanced MRI scan of the liver
    (obtained as part of usual clinical practice).

    Exclusion Criteria:

    1. Standard MRI safety screening criteria will be employed, and subject will be excluded
    if any contraindications to undergo MRI are met.

    2. Subjects with metallic biliary stents or multiple peripancreatic surgical clips on
    abdominal MDCT will be excluded.

    3. Subjects on hemodialysis or with glomerular filtration rate (GFR) less than 30 will
    be excluded.

    4. Subjects will not be excluded on the basis of gender, race, ethnicity, or religion.

    5. Subject may not be pregnant or lactating.
  • Age minimum:  19 Years
  • Age maximum:  N/A
  • Gender:  Both
Primary outcomes:
To obtain bi-directional measurements of hilar cholangiocarcinoma tumor in centimeters, on the Dual Energy CT scan images.
Secondary outcomes:
Target sample size:
43
Study type:
Interventional
Study design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Contacts:

Technical details

Scientific title:
The Role of Gadoxetate Enhanced Spectral Dual-Energy CT in Evaluating Hilar Cholangiocarcinoma
Sources of monetary support:
Please refer to primary and secondary sponsors
Secondary sponsors:
Society of Abdominal Radiology
Main ID:
NCT01673802
Secondary ID:
R11-153
117354
Register:
ClinicalTrials.gov
Date of registration:
13/08/2012
Date of first enrollment:
August 2012
Last refreshed:
25 February 2013

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