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

NCT01673802 | Completed Early Phase 1 Results

• 2 other identifiers: R11-153117354
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Cholangiocarcinoma

Keywords

Cholangiocarcinoma

Outcome Measures

Primary Outcomes (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

  24 hrs

Study Arms (1)

CT imaging

EXPERIMENTAL

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.

Drug: CT scan

Interventions

CT scan DRUG

Gadoxetate (Eovist) enhanced dual energy CT

Also known as: Dual Energy CT

CT imaging

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Society of Abdominal Radiology: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Cholangiocarcinoma

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Results Point of Contact

• Title: John V. Thomas, MD; Principal Investigator
• Organization: University of Alabama at Bimringham

jvthomas@uabmc.edu

205-996-4132

Study Officials

• John V Thomas, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Single arm study, with dose adjustment.

Study Record Dates

• First Submitted: August 13, 2012
• First Posted: August 28, 2012
• Study Start: August 1, 2012
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: June 1, 2017
• Results First Posted: June 20, 2014

Record last verified: 2017-04

Locations

US (1)