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Completed

NCT Number: NCT01192360

Dynamic Contrast Enhanced Magnetic Resonance Perfusion Imaging in Congenital Heart Disease and Lung Disease

The primary objective of this study is to determine if quantitative Dynamic contrast-enhanced magnetic resonance (DCE MR) perfusion imaging accurately quantifies right and left pulmonary artery blood flow as compared with phase contrast flow velocity mapping (PC), the current gold standard of flow volume measurements.

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Key information

About this study

Many conditions of the heart or the lungs lead to differences in how the blood is pumped to the lungs. Specifically, some areas of the lung may receive less blood supply than others. We would like to do a research study in children and adolescents who have a heart condition or a chronic or stable lung condition. We are doing this study to see if measuring the circulation of blood in the lungs in children is possible using magnetic resonance imaging (MRI) with a special dye (contrast medium) injection called Magnevist®.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Cardiac Patients:

  • Patients > 6 years of age
  • Patients with suspected or confirmed congenital or acquired heart disease
  • Who undergo a clinically indicated MRI scan, including gadolinium (MRI contrast medium)
  • And receive gadolinium (= MRI contrast medium) as part of their clinical investigation

Pulmonary Patients:

  • Patients > 6 years of age
  • Patients with a chronic and stable lung condition, such as cystic fibrosis, severe asthma.

Exclusion criteria

  • Children under the age of 6 will be excluded as they are routinely scanned under general anesthesia
  • Patients in whom MRI is contraindicated (e.g. pacemaker, ocular metal, claustrophobia, tattoos)
  • Patients with a known allergy to gadolinium.
  • Patients with a history of allergic disposition or have anaphylactic reactions
  • Moderate-to-severe renal impairment (defined as having a GFR/ eGFR < 60 mL/min)
  • Have Sickle Cell anemia
  • Known pregnancy, or breast feeding
  • Patient is uncooperative during a MRI without sedation or anesthesia

Treatment and study plan

Phase contrast flow velocity mapping (PC)

Procedure

An MRI is done using the phase contrast flow velocity mapping (PC)technique. Using PC, an imaging slice is prescribed perpendicular to the vessel's course. Within the pulmonary circulation, PC can quantify total pulmonary blood flow and the right / left distribution of the lung blood flow volume.

Dynamic Contrast-Enhanced Magnetic Resonance Imaging

Procedure

Dynamic contrast-enhanced magnetic resonance (DCE MR) perfusion imaging imaging is a non-invasive method to quantify regional pulmonary blood flow. A bolus of gadolinium-containing contrast medium is injected and its passage through the pulmonary circulation traced using a repetitive rapid three-dimensional (3D) T1 weighted angiography sequence.

Primary outcomes

  1. Pulmonary blood flow

    Time frame: 1 hour

    Pulmonary blood flow as measured with DCE MRI perfusion imaging will be compared to MRI phase contrast imaging, which is the gold standard of non-invasive flow measurements.

Secondary outcomes

  1. Perfusion defects detected

    Time frame: 1 hour

    Perfusion defects (number and location) will be compared to images of lung morphology and correlated with pathology within the lung parenchyma and central airways.

  2. Quantitative results from dynamic contrast-enhanced magnetic resonance perfusion imaging

    Time frame: 1 hour

    Quantitative results from DCE MRI perfusion imaging (including mean transit time, pulmonary blood flow, pulmonary blood volume) will be correlated with the results of pulmonary perfusion tests, where clinically available.

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Sep 1, 2010
Registry last updated
Jul 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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