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Clinical Trials/NCT01192360
NCT01192360
Completed
Phase 3

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

The Hospital for Sick Children1 site in 1 country16 target enrollmentSeptember 2010

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Heart Disease
Sponsor
The Hospital for Sick Children
Enrollment
16
Locations
1
Primary Endpoint
Pulmonary blood flow
Status
Completed
Last Updated
6 years ago

Overview

Brief Summary

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.

Detailed Description

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®.

Registry
clinicaltrials.gov
Start Date
September 2010
End Date
December 2012
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lars Grosse-Wortmann

Principal Investigator

The Hospital for Sick Children

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • Perfusion defects detected(1 hour)
  • Quantitative results from dynamic contrast-enhanced magnetic resonance perfusion imaging(1 hour)

Study Sites (1)

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