Physiologic Assessment Following Gadoxetic Acid and Gadobenate Dimeglumine Administration

NCT02226666 | Completed

• 1 other identifier: HUM00075454
• Study Type: observational
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to prospectively compare the physiologic response of patients who receive either intravenous gadoxetic acid (Eovist) or intravenous gadobenate dimeglumine (MultiHance).

Conditions

Liver Tumor

Keywords

MRI; Eovist; MultiHance

Outcome Measures

Primary Outcomes (1)

• Survey

  Subjects fill out a short 5-question survey about their MRI experience directly following clinical MRI scan.

  Baseline

Secondary Outcomes (2)

• Oxygen Levels

  Baseline

• Respiratory Rate

  Baseline

Study Arms (2)

Patients having MRI with Eovist

Subjects having a clinically ordered MRI with Eovist. Patients consenting for the study will be monitored before and after getting MRI contrast. For the study oxygen saturation (amount of oxygen level in the blood) and breathing will be monitored during the can. Breathing will be measured with a non-invasive respiratory monitoring device attached to the MR scanner. Each patient will answer survey questions after the scan about their experiences concerning MRI contrast.

Drug: MRI with Eovist

Patients having MRI with Multihance

Subjects having a clinically ordered MRI with Multihance. Patients consenting for the study will be monitored before and after getting MRI contrast. For the study oxygen saturation (amount of oxygen level in the blood) and breathing will be monitored during the scan. Breathing will be measured with a non-invasive respiratory monitoring device attached to the MR scanner. Each patient will answer survey questions after the scan about their experiences concerning MRI contrast.

Drug: MRI with Multihance

Interventions

MRI with Multihance DRUG

Patients will have Multihance used as an IV contrast agent for their scan.

Also known as: gadobenate dimeglumine

Patients having MRI with Multihance

MRI with Eovist DRUG

Patients will have Eovist used as an IV contrast agent for their scan.

Also known as: Gadoxetate disodium

Patients having MRI with Eovist

Eligibility Criteria

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

Study Population

One-hundred patients receiving gadoxetic acid for hepatobiliary indications and 100 patients receiving gadobenate dimeglumine for hepatobiliary indications will be studied prospectively. All patients will be scheduled to undergo MRI for clinical purposes by their primary care physicians. The patients will not be randomized.

You may qualify if:

• Patients 18 years old and older
• Patients scheduled for MRI examination at the University of Michigan hospital
• Patients receiving either MultiHance or Eovist contrast agents during their clinical MRI examination

You may not qualify if:

• Patients under 18 years of age
• Patients who will not receive MultiHance or Eovist as part of their clinical MRI examination

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Magnetic Resonance Spectroscopy; gadobenic acid; gadolinium ethoxybenzyl DTPA

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Matthew Davenport, MD

  University of Michigan Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: August 22, 2014
• First Posted: August 27, 2014
• Study Start: August 1, 2013
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: January 13, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)