Dotarem Evaluation for Myocardial Perfusion CMR

NCT03937921 | Completed FDA Drug

• 1 other identifier: 80969
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The overall goal of this study is to investigate the signal intensity and relaxation rate characteristics of gadoterate meglumine (Dotarem, Guerbet, USA) enhanced myocardium during rest and stress perfusion cardiovascular magnetic resonance (CMR) compared to gadobutrol (Gadavist) to prove that Dotarem provides constantly high myocardial relaxation necessary for accurate quantitative perfusion evaluation. The purpose of this study is to compare two types of contrast that patients receive during cardiac MRI scans to visualize the blood flow in the cardiac muscle. Both contrasts are used in standard of care procedures, and the one administered for each patient will be randomly selected. The length of the MRI study all procedures are the same as the clinically indicated scan.

Conditions

Myocardial Perfusion Imaging; Magnetic Resonance Imaging

Keywords

Signal intensity enhancement; Relaxation rate enhancement

Outcome Measures

Primary Outcomes (1)

• Signal intensity of gadoterate meglumine during perfusion cardiovascular magnetic resonance

  Characteristics of signal intensity changes and absolute myocardial blood flow using the MASS Research Software; signal intensity-time curves from the perfusion data

  1 year

Secondary Outcomes (1)

• Relaxation rate characteristics of gadoterate meglumine during perfusion cardiovascular magnetic resonance

  1 year

Study Arms (2)

Group 1 - Dotarem

Group 1 (n=30) will receive the clinically approved gadoterate meglumine (Dotarem, 0.1mmol/kg) as the contrast agent for their clinical perfusion study

Group 2 - Gadavist

Group 2 (n=30) will receive the clinically approved gadobutrol (Gadavist, 0.1mmol/kg) as the contrast agent.

Drug: Gadavist 15Ml Solution for Injection

Interventions

Gadavist 15Ml Solution for Injection DRUG

Group 2 (n=30) will receive the clinically approved gadobutrol (Gadavist, 0.1mmol/kg) as contrast agent. The contrast agents will be administered at a flow rate of 5.0 ml/s for both groups. In this study aim, all imaging protocols will comply with standard of care and only the perfusion data will be post-processed and analyzed.

Group 2 - Gadavist

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

There will not be any eligibility criteria for any subpopulations. In addition, there will not be any targeted involvement of special classes of subjects, such as fetuses, neonates, pregnant women, children, prisoners, institutionalized individuals, or others who may be considered vulnerable populations. All race and ethnicities and both genders will be considered for inclusion into the study. Subjects under the age of 18 will not be considered for inclusion into this study.

You may qualify if:

• To be eligible for the study: (All answers must be "YES" for subject to be eligible.)
• Subject must be referred for a clinically indicated contrast-enhanced stress myocardial perfusion MRI scan out of concern of suspected myocardial ischemia.
• Subject must be older than 18 years of age.
• Subject must provide written informed consent prior to any study-related procedures being performed.
• Subject must be willing to comply with all clinical study procedures.

You may not qualify if:

• The presence of the following excludes subjects from the study: (All answers must be "NO" for subject to be eligible.)
• Subject is a pregnant or nursing female. Exclude the possibility of pregnancy:
• By testing (serum or urine beta HCG) within 24 hours before study date, or
• By surgical sterilization, or
• Post-menopausal, with minimum one (1) year history without menses.
• Subject has an implanted cardiac pacemaker or implantable defibrillator.
• Subject has a ferromagnetic vascular clip.
• Subject has a neurostimulation system (e.g. TENS-Unit).
• Subject has any type of cochlear implant.
• Subject has ocular foreign body (e.g. metal shavings).
• Subject carries any implanted device (e.g. insulin pump, drug infusion device).
• Subject has shrapnel, bullet, or other type of metal fragments within the body.
• Subject has an acute psychiatric disorder or is cognitively impaired.
• Subject is using or is dependent on substances of abuse.
• Subject is unwilling to comply with the requirements of the protocol.

Sponsors & Collaborators

• Medical University of South Carolina: lead
• Guerbet: collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Interventions

gadobutrol; Solutions; Injections

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Joseph U. Schoepf, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: May 6, 2019
• Study Start: July 3, 2019
• Primary Completion: October 31, 2024
• Study Completion: October 31, 2024
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)