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Contrast-enhanced MRI in Detecting Benign and Malignant Liver Lesions

Primary Purpose

Hepatocellular Carcinoma, Liver and Intrahepatic Bile Duct Disorder, Metastatic Malignant Neoplasm in the Liver

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Contrast-enhanced Magnetic Resonance Imaging
Gadobutrol
Gadoxetate Disodium
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with the most recent abdominal magnetic resonance (MR) study obtained within 3 months +/- 1 week
  • Patients with renal function (estimated glomerular filtration rate [eGFR] >= 30)
  • Any disease type

Exclusion Criteria:

  • Pregnant women
  • Patients with impaired renal function (eGFR < 30)
  • Patients with surgical implants and/or metallic foreign bodies non-compatible with the MR magnet
  • Patients with contraindications to the use of intravenous contrast such as allergic type reactions

Sites / Locations

  • M D Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (contrast-enhanced MRI)

Arm Description

Patient receives each of these over one minute. For the gadoxetate disodium, dynamic imaging is performed immediately and imaging is performed at 20 minutes. For the gadobutrol, dynamic imaging is performed immediately.

Outcomes

Primary Outcome Measures

Specificity of combining gadoxetate disodium and gadobutrol in diagnosing tumor lesions radiologically using magnetic resonance imaging (MRI)
Summary statistics of sensitivity, specificity, true positives, true negatives, false positives, and false negatives will be provided for gadoxetate disodium and gadoxetate disodium + gadobutrol method. Accuracy, sensitivity, specificity, positive predictive value, and negative predictive value will be estimated along with corresponding 95% confidence intervals for the two methods. Comparison between the two methods will be made following method by Obuchowski. Other statistical analyses will be carried out as appropriate.

Secondary Outcome Measures

Full Information

First Posted
June 3, 2014
Last Updated
September 26, 2023
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02156739
Brief Title
Contrast-enhanced MRI in Detecting Benign and Malignant Liver Lesions
Official Title
Radiologic Detection and Characterization of Benign and Malignant Liver Lesions in Contrast-Enhanced MRI
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 13, 2014 (Actual)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This clinical trial studies contrast-enhanced magnetic resonance imaging (MRI) in detecting nonmalignant and malignant liver lesions. Diagnostic procedures, such as MRI, may help find and diagnose nonmalignant and malignant liver lesions. Contrast agents, such as gadoxetate disodium and gadobutrol, may help doctors to see MRI images more clearly.
Detailed Description
PRIMARY OBJECTIVES: I. To compare the specificity of contrast enhanced MRI using a liver specific agent Eovist (gadoxetate disodium) versus the combined use of Eovist and an intravascular-extracellular agent Gadavist (gadobutrol) for the radiologic detection and characterization of liver lesions via clinical stability and follow up imaging. OUTLINE: Patients receive gadoxetate disodium intravenously (IV) over 1 minute and undergo MRI. Patients then receive gadobutrol IV over 1 minute at the 20 minute mark during MRI.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma, Liver and Intrahepatic Bile Duct Disorder, Metastatic Malignant Neoplasm in the Liver, Primary Malignant Liver Neoplasm

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (contrast-enhanced MRI)
Arm Type
Experimental
Arm Description
Patient receives each of these over one minute. For the gadoxetate disodium, dynamic imaging is performed immediately and imaging is performed at 20 minutes. For the gadobutrol, dynamic imaging is performed immediately.
Intervention Type
Procedure
Intervention Name(s)
Contrast-enhanced Magnetic Resonance Imaging
Other Intervention Name(s)
CONTRAST ENHANCED MRI, Contrast-enhanced MRI
Intervention Description
Undergo contrast-enhanced MRI
Intervention Type
Drug
Intervention Name(s)
Gadobutrol
Other Intervention Name(s)
BAY86-4875, Gadavist, Gadograf, Gadovist, Protovis, ZK 135079
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Gadoxetate Disodium
Other Intervention Name(s)
Eovist, Gadolinium EOB DTPA, Gadolinium Ethoxybenzyl Diethylenetriaminepentaacetic Acid, Gadoxetic Acid Disodium, Gd-(S)-EOB-DTPA, Gd-EOB-DTPA, Primovist, ZK 139834
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Specificity of combining gadoxetate disodium and gadobutrol in diagnosing tumor lesions radiologically using magnetic resonance imaging (MRI)
Description
Summary statistics of sensitivity, specificity, true positives, true negatives, false positives, and false negatives will be provided for gadoxetate disodium and gadoxetate disodium + gadobutrol method. Accuracy, sensitivity, specificity, positive predictive value, and negative predictive value will be estimated along with corresponding 95% confidence intervals for the two methods. Comparison between the two methods will be made following method by Obuchowski. Other statistical analyses will be carried out as appropriate.
Time Frame
Up to 4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with the most recent abdominal magnetic resonance (MR) study obtained within 3 months +/- 1 week Patients with renal function (estimated glomerular filtration rate [eGFR] >= 30) Any disease type Exclusion Criteria: Pregnant women Patients with impaired renal function (eGFR < 30) Patients with surgical implants and/or metallic foreign bodies non-compatible with the MR magnet Patients with contraindications to the use of intravenous contrast such as allergic type reactions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janio Szklaruk, MD, PHD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
University of Texas MD Anderson Cancer Center Website

Learn more about this trial

Contrast-enhanced MRI in Detecting Benign and Malignant Liver Lesions

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