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

Phase 3

Completed

• Conditions: Asthma; Cystic Fibrosis; Heart Disease
• Interventions: Procedure: Phase contrast flow velocity mapping (PC); Procedure: Dynamic contrast-enhanced magnetic resonance imaging

• Registration Number: NCT01192360
• Lead Sponsor: The Hospital for Sick Children

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®.

Study Timeline

• Study First Submitted: 2010-08-30
• Study First Submitted QC: 2010-08-30
• Study Start: 2010-09
• Study First Posted: 2010-09-01
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-02
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cardiac Patients	Phase contrast flow velocity mapping (PC)	In addition to the routine clinical MRI, we will conduct the DCE MR perfusion imaging research component. For this, we will measure native pre-contrast T1 and then inject a tight bolus of gadolinium (0.1mmol/kg) while acquiring high temporal resolution T1-weighted 3D contrast dynamics information over the whole thorax while the patient is holding his / her breath. Overall, the research component will prolong the clinical study by approximately 5 minutes.
Cardiac Patients	Dynamic contrast-enhanced magnetic resonance imaging	In addition to the routine clinical MRI, we will conduct the DCE MR perfusion imaging research component. For this, we will measure native pre-contrast T1 and then inject a tight bolus of gadolinium (0.1mmol/kg) while acquiring high temporal resolution T1-weighted 3D contrast dynamics information over the whole thorax while the patient is holding his / her breath. Overall, the research component will prolong the clinical study by approximately 5 minutes.
Pulmonary Patients	Dynamic contrast-enhanced magnetic resonance imaging	Patients in this group will receive a full cardiac and pulmonary MRI assessment, with the DCE pulmonary perfusion scan added as described above. Overall, the investigation will take approximately 45 minutes
Pulmonary Patients	Phase contrast flow velocity mapping (PC)	Patients in this group will receive a full cardiac and pulmonary MRI assessment, with the DCE pulmonary perfusion scan added as described above. Overall, the investigation will take approximately 45 minutes

Primary Outcome Measures

Name	Time	Method
Pulmonary blood flow	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 Outcome Measures

Name	Time	Method
Perfusion defects detected	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.
Quantitative results from dynamic contrast-enhanced magnetic resonance perfusion imaging	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.

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada