Improving the Concentration of MR Contrast in the Arteries

NCT02155218 | Completed

• 1 other identifier: STUDY00001892
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

In Contrast-Enhanced Magnetic Resonance Angiography (CE-MRA) a contrast agent is injected into an arm vein using a programmable medical device called a power injector. Once the contrast has circulated to the blood vessel of interest they can be imaged with MRI and distinctly separated from surrounding non-vascular tissue. This project is designed to find the best way to administer the contrast agent during CE-MRA to produce the best images. The clinical availability of programmable power injectors facilitates the use of variable contrast rate and volume injection protocols that are based on patient specific parameters. CE-MRA is a valuable imaging tool for diagnosing abnormalities of the major blood vessels in the chest and abdomen. It is often used in conjunction with cardiac magnetic resonance (CMR) examinations to evaluate the blood vessels of the heart and lung. CE-MRA is attractive because 1) it does not involve radiation, and 2) the contrast agents used are not toxic to the kidneys and can be used in patients who are at greater risk for kidney dysfunction following iodinated contrast agents. We plan to administer a small (1cc) test amount of contrast, taking pictures as the contrast passes through the blood vessels, and analyze the results. Using this information, we will administer an individually patient-tailored injection given in multiple phases (i.e., a "multi-phasic" injection) to maintain constant contrast concentration (and therefore constant signal intensity) throughout the scan. We believe this will reduce image blurring, and improve the sharpness and likely the diagnostic quality of CE-MRA.

Conditions

Magnetic Resonance Angiography; Contrast Media

Keywords

Magnetic Resonance Angiography; Contrast Media

Outcome Measures

Primary Outcomes (1)

• Arterial Signal Intensity Evaluation

  To evaluate the performance of the bolus-tailoring method, measured signal intensity profiles will be evaluated using residual sum-of-squares (RSS) between targeted and measured responses. A smaller RSS indicates agreement with the targeted signal intensity profile. Additionally, full-width-at-half-maximum (FWHM) and start time (10% signal intensity increase over baseline) of the signal intensity profile will be measured and compared between the two groups. T-test will be used to test for significant differences between the two methods.

  During the one-time contrast-enhanced cardiac MR exam lasting approximately 45 to 60 minutes, signal intensity will be evaluated continuously before, during and after administration of contrast.

Study Arms (2)

Standard Injection Rate

ACTIVE COMPARATOR

Subjects will be given a small amount of contrast (approximately 1 cc test bolus) followed by administration of the remainder of the volume of contrast they are getting for their clinical study. This will be approximately 30-40 cc, depending on patient size, given at an injection rate of 2 - 2.5 cc/second.

Other: Standard Injection Rate; Other: gadolinium contrast

Patient Tailored Injection Rate

EXPERIMENTAL

Subjects will be given a small amount of contrast (approximately 1 cc test bolus) followed by administration of the remainder of the volume of contrast they are getting for their clinical study. This will be approximately 30-40 cc, depending on patient size. We will use a mathematical algorithm to rapidly analyze the test bolus and calculate a predicted "best" way to inject the contrast - likely slower and "multi-phasic", meaning different flow rates as the bolus injection evolves. The injection rate will vary from 1 to 3 cc/second.

Other: Patient Tailored Injection Rate; Other: gadolinium contrast

Interventions

Standard Injection Rate OTHER

Normally an IV is placed in an arm and the gadolinium contrast (30-40 cc, depending on patient size) is administered through the IV with a power injector as a single bolus. Subjects will have a test bolus and main bolus.

Standard Injection Rate

Patient Tailored Injection Rate OTHER

Normally an IV is placed in an arm and the gadolinium contrast (30-40 cc, depending on patient size) is administered through the IV with a power injector as a single bolus. Subjects will have a test bolus and main bolus. We will use a mathematical algorithm to rapidly analyze the test bolus and calculate a predicted "best" way to inject the main bolus - likely slower and "multi-phasic", meaning different flow rates as the bolus injection evolves.

Patient Tailored Injection Rate

gadolinium contrast OTHER

Patient Tailored Injection Rate; Standard Injection Rate

Eligibility Criteria

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

You may qualify if:

• years of age or older;
• Scheduled at University of Washington Radiology to undergo contrast-enhanced cardiac MR.

You may not qualify if:

• Unable to understand the nature of the study or to consent;
• Unwilling to participate;
• Prisoner;
• Pregnant;
• Contraindications for MRI:
• Metallic or other surgical implants
• History of metal work; metal pieces in your eyes or other body parts
• pacemaker
• defibrillator
• some aneurysm clips
• some artificial heart valves
• some implanted venous access device
• some cochlear/inner ear implants
• spinal stimulator
• some intrauterine devices (IUD)

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Related Publications (1)

• Wilson GJ, Maki JH. Evaluation of a tailored injection profile (TIP) algorithm for uniform contrast-enhanced signal intensity profiles in MR angiography. J Magn Reson Imaging. 2016 Dec;44(6):1664-1672. doi: 10.1002/jmri.25298. Epub 2016 May 5.

  PMID: 27149390 RESULT

MeSH Terms

Interventions

gadolinium compound P760

Study Officials

• Jeffrey H. Maki, MD, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Radiology

Study Record Dates

• First Submitted: June 2, 2014
• First Posted: June 4, 2014
• Study Start: June 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: November 1, 2015
• Last Updated: October 26, 2017

Record last verified: 2017-10

Locations

US (1)