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

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

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01192360
Enrollment
16
Registered
2010-09-01
Start date
2010-09-30
Completion date
2012-12-31
Last updated
2019-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Cystic Fibrosis, Heart Disease

Keywords

pediatrics, Heart Disease, Cystic Fibrosis, Severe Asthma, Magnetic Resonance Imaging

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®.

Interventions

PROCEDUREPhase contrast flow velocity mapping (PC)

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.

PROCEDUREDynamic contrast-enhanced magnetic resonance imaging

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.

Sponsors

The Hospital for Sick Children
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Cardiac Patients: 1. Patients \> 6 years of age 2. Patients with suspected or confirmed congenital or acquired heart disease 3. Who undergo a clinically indicated MRI scan, including gadolinium (MRI contrast medium) 4. And receive gadolinium (= MRI contrast medium) as part of their clinical investigation Pulmonary Patients: 1. Patients \> 6 years of age 2. Patients with a chronic and stable lung condition, such as cystic fibrosis, severe asthma.

Exclusion criteria

1. Children under the age of 6 will be excluded as they are routinely scanned under general anesthesia 2. Patients in whom MRI is contraindicated (e.g. pacemaker, ocular metal, claustrophobia, tattoos) 3. Patients with a known allergy to gadolinium. 4. Patients with a history of allergic disposition or have anaphylactic reactions 5. Moderate-to-severe renal impairment (defined as having a GFR/ eGFR \< 60 mL/min) 6. Have Sickle Cell anemia 7. Known pregnancy, or breast feeding 8. Patient is uncooperative during a MRI without sedation or anesthesia

Design outcomes

Primary

MeasureTime frameDescription
Pulmonary blood flow1 hourPulmonary 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

MeasureTime frameDescription
Perfusion defects detected1 hourPerfusion defects (number and location) will be compared to images of lung morphology and correlated with pathology within the lung parenchyma and central airways.
Quantitative results from dynamic contrast-enhanced magnetic resonance perfusion imaging1 hourQuantitative 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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026