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CholangiocarcinomaEarly Phase 1NCT01673802

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

A Early Phase 1 study testing CT scan in people with Cholangiocarcinoma, run by University of Alabama at Birmingham at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 19 years and older
Conditions the study is for
Cholangiocarcinoma
What is being tested?
CT scan
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteUnited States
Study dates
Aug 2012to Jan 2014
Phase
Early Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects will be adult (age 19 or older) with suspected cholangiocarcinoma of the liver.
  • Subject must be able to provide a written informed consent.
  • Subject will be scheduled for gadoxetate contrast enhanced MRI scan of the liver (obtained as part of usual clinical practice).

Who cannot join

  • Standard MRI safety screening criteria will be employed, and subject will be excluded if any contraindications to undergo MRI are met.
  • Subjects with metallic biliary stents or multiple peripancreatic surgical clips on abdominal MDCT will be excluded.
  • Subjects on hemodialysis or with glomerular filtration rate (GFR) less than 30 will be excluded.
  • Subjects will not be excluded on the basis of gender, race, ethnicity, or religion.
  • Subject may not be pregnant or lactating.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

Other trials in United States

About this study

Official title: The Role of Gadoxetate Enhanced Spectral Dual-Energy CT in Evaluating Hilar Cholangiocarcinoma

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.

Read the 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.

Being tested
CT scan
Keywords
Cholangiocarcinoma
Medical subject headings
Cholangiocarcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CT scanDrug

    Also called Dual Energy CT

    Gadoxetate (Eovist) enhanced dual energy CT

Study groups in NCT01673802
Study groupRoleWhat they receive
CT imagingExperimentalPatients 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.
Receives: Drug: CT scan

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Subjects Where Hilar Cholangiocarcinomas Could be Visualized Using Gadoxetate Disodium Enhanced Dual Energy CT

    CT scans were assessed for tumor visualization after use of Gadoxetate disodium

    Measured: 24 hrs

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2012 (estimated)
  2. Study startAug 2012
  3. Primary completionJan 2014
  4. Study completionJan 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Single arm study, with dose adjustment.
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01673802
Sponsor's protocol ID
R11-153
Other IDs
117354
Status last verified
Apr 2017
First submitted
13 Aug 2012
Last updated
1 Jun 2017
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing CT scan in people with Cholangiocarcinoma, run by University of Alabama at Birmingham at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Subjects Where Hilar Cholangiocarcinomas Could be Visualized Using Gadoxetate Disodium Enhanced Dual Energy CT (time frame: 24 hrs). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2017.

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