Clinical trial NCT01192360: Dynamic Contrast Enhanced Magnetic Resonance Perfusion Imaging in Congenital Heart Disease and Lung Disease
Official title: Dynamic Contrast Enhanced Magnetic Resonance Perfusion Imaging in Congenital Heart Disease and Lung Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heart Disease
Cystic Fibrosis
Asthma
Keywords: pediatrics
Heart Disease
Cystic Fibrosis
Severe Asthma
Magnetic Resonance Imaging
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2010-09-01
Enrollment: 16
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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®.

Eligibility criteria: 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

Primary outcomes:
measure: Pulmonary blood flow
timeFrame: 1 hour
Secondary outcomes:
measure: Perfusion defects detected
timeFrame: 1 hour
measure: Quantitative results from dynamic contrast-enhanced magnetic resonance perfusion imaging
timeFrame: 1 hour
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children, Toronto Canada
name: Lars Grosse-Wortmann, MD
role: PRINCIPAL_INVESTIGATOR
References: