Evaluation of Transient Dyspnea During Gadoxetic Acid Enhanced Multiphasic Liver MRI

NCT02395991 | Completed Results DMC

• 1 other identifier: CS_2015_ISS
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to observe transient dyspnea pattern after Gd-EOB-DTPA administration by obtaining continuous dynamic T1 weighted image data.

Conditions

Dyspnea

Keywords

gadoxetic acid; transient dyspnea

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Transient Dyspnea.

  A sudden onset irregular breathing pattern after EOB administration, based on MRI k-space data (not participants' symptom). The k-space data was analyzed after the enrollment completion.

  during 3 minutes after contrast media administration

Secondary Outcomes (1)

• Duration of Transient Dyspnea in Participants With Transient Dyspnea.

  during 3 minutes after contrast media administration

Other Outcomes (1)

• Liver Stiffness Value

  in three days after MRI

Study Arms (1)

Observe1

Patients who are referred to MR unit for hepatocyte-specific contrast (gadoxetic acid) enhanced liver magnetic resonance imaging (MRI)

Drug: gadoxetic acid; Other: Magnetic resonance imaging (MRI)

Interventions

gadoxetic acid DRUG

standard dose of gadoxetic acid (0.025mmol/kg) intravenous administration

Also known as: eovist, primovist

Observe1

Magnetic resonance imaging (MRI) OTHER

Dynamic T1 weighted sequence consist of precontrast, arterial, portal, transitional and hepatobiliary phases. precontrast, arterial and portal phases (prior to contrast media injection to 60 seconds after contrast media injection) are obtained continuously in free-breathing state. Transitional and hepatobiliary phases are obtained in breath-hold state.

Observe1

Eligibility Criteria

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

Study Population

Patients who are referred to MR unit for hepatocyte-specific contrast enhanced liver MRI using gadoxetic acid.

You may qualify if:

• Patients who are referred to MR unit for hepatocyte-specific contrast enhanced liver MRI using gadoxetic acid, to characterize focal liver lesion or to investigate diffuse liver disease
• OR, Liver living donor candidates
• AND subjects who sign the informed consent.

You may not qualify if:

• Minors under 18 years old
• All contraindication to MRI
• Hypersensitivity to Gd
• Biliary obstruction

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Bayer: collaborator

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Dyspnea

Interventions

gadolinium ethoxybenzyl DTPA; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Results Point of Contact

• Title: Professor Jeong Min Lee
• Organization: Seoul National University Hospital

jmsh@snu.ac.kr

82-2-2072-3154

Study Officials

• Jeong Min Lee, MD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Study Record Dates

• First Submitted: March 18, 2015
• First Posted: March 24, 2015
• Study Start: April 1, 2015
• Primary Completion: October 1, 2016
• Study Completion: February 1, 2018
• Last Updated: May 26, 2021
• Results First Posted: May 26, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)