Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Society of Abdominal Radiology
Information provided by (Responsible Party):
John V. Thomas, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01673802
First received: August 13, 2012
Last updated: May 20, 2014
Last verified: May 2014
  Purpose

The purpose of this project is to evaluate the role of gadoxetate (Eovist®) enhanced dual-energy CT in better evaluating perihilar cholangiocarcinoma. This pilot project aims to address a long-term pitfall in the imaging of cholangiocarcinomas, by providing higher resolution delineation of these often infiltrative tumors on single-source, Dual-Energy Spectral Multi Detector CT (MDCT), capitalizing on improved spatial resolution achievable with MDCT compared to MRI and at the same time producing a non-invasive CT cholangiogram to aid in accurate diagnosis and treatment planning of cholangiocarcinoma, particularly, the hilar variety.


Condition Intervention Phase
Cholangiocarcinoma
Radiation: CT scan
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: The Role of Gadoxetate Enhanced Spectral Dual-Energy CT in Evaluating Hilar Cholangiocarcinoma

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Number of Subjects Where Hilar Cholangiocarcinomas Could be Visualized Using Gadoxetate Disodium Enhanced Dual Energy CT [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]
    CT scans were assessed for tumor visualization after use of Gadoxetate disodium


Enrollment: 19
Study Start Date: August 2012
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CT imaging
Patients will undergo a standard of care Gadoxetate (Eovist) MRI for cholangiocarcinoma. Patients will then be immediately placed on the CT scanner. Patients will undergo a dual energy CT of the abdomen with no additional contrast.
Radiation: CT scan
Gadoxetate (Eovist) enhanced dual energy CT
Other Name: Dual Energy CT

Detailed Description:

The purpose of this project is to evaluate the role of gadoxetate (Eovist) enhanced dual-energy CT in better evaluating perihilar cholangiocarcinoma, by exploiting the combination of the physiologic behavior of gadoxetate in liver tissue combined with the advantageous mass attenuation coefficient of Gadolinium achievable through dual energy technique. This combination of unique CT imaging sensitivity, high resolution and differential enhancement potentially allows improved visualization and detection of tumor relative to enhancing surrounding hepatic parenchyma and ductal anatomy in the hepatobiliary phase, due to the biliary excretion of the agent.

Cholangiocarcinoma is a hepatic adenocarcinoma that arises from the bile duct epithelium and is the second most prevalent liver cancer after hepatocellular carcinoma. The hilar intrahepatic variety of cholangiocarcinoma can present as an infiltrative, exophytic, or polypoid lesion. Most extra-hepatic cholangiocarcinomas are infiltrative, causing a focal stricture of the bile duct and result in proximal biliary ductal dilatation.

While magnetic resonance (MR) cholangiography is diagnostic in the majority of patients with malignant hilar strictures, evaluation is limited by spatial resolution and in some patients, the inability to have an MRI scan. Standard Multi Detector CT (MDCT) using iodinated contrast agents, on the other hand, is limited in evaluation of cholangiocarcinomas, due to the lack of consistent enhancement of the tumor with iodinated contrast.

Single-source, Dual-Energy (SSDE) Spectral MDCT utilizes a single fast switching x-ray beam source to acquire near simultaneous data sets at two different photon energies during a single acquisition. Data is acquired at 80 kilovolt peak (kVp) and 140 kVp with image reconstruction achievable as a selectable monochromatic presentation over a range of 40 - 140 kiloelectron volt (keV), typically 70-78 keV for diagnostic image presentation. At lower tube voltage, the frequency of photoelectric interactions increases exponentially and is strongly dependent on the atomic number. Therefore, for substances with higher atomic number, such as iodine and gadolinium the increased frequency of photoelectric and k-edge interactions at low tube voltage substantially increases CT attenuation, thus improving contrast. Gadolinium is further unique with k-edge attenuation at approximately 53 keV, within the available monochromatic reconstruction range, thus allowing for significant greater detectability. Additional material decomposition technique allows for unique material presentation and analysis such as gadolinium/ water pair analysis with high spatial resolution.

Dual-Energy technology is limited by the types of contrast agents currently available, all based on Iodine. Gadoxetate (Eovist) is a relatively new Gadolinium based MRI contrast agent that is capable of producing not only standard appearing MRI images in the hepatic arterial and portal venous phases, but also provides an opportunity to better visualize the bile ducts and liver parenchyma as it is excreted by the liver into the biliary system during the hepatobiliary phase.

This pilot project aims to address a long-term pitfall in the imaging of cholangiocarcinomas, by providing higher resolution delineation of these often infiltrative tumors on single-source, Dual-Energy Spectral MDCT, capitalizing on improved spatial resolution achievable with MDCT compared to MRI and at the same time producing a non-invasive CT cholangiogram to aid in accurate diagnosis and treatment planning of cholangiocarcinoma, particularly, the hilar variety.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01673802

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Society of Abdominal Radiology
Investigators
Principal Investigator: John V Thomas, MD University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: John V. Thomas, Associate Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01673802     History of Changes
Other Study ID Numbers: R11-153, 117354
Study First Received: August 13, 2012
Results First Received: May 20, 2014
Last Updated: May 20, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
Cholangiocarcinoma

Additional relevant MeSH terms:
Cholangiocarcinoma
Adenocarcinoma
Carcinoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Gadolinium ethoxybenzyl DTPA
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2014