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

The Hospital for Sick Children

Status and phase: Completed; Phase 3

Conditions: Asthma; Cystic Fibrosis; Heart Disease

Treatments: Procedure: Phase contrast flow velocity mapping (PC); Procedure: Dynamic contrast-enhanced magnetic resonance imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT01192360

1000016503

Details and patient eligibility

About

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.

Full 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®.

Enrollment: 16 patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 2 patient groups

Cardiac Patients

Experimental group

Description:

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.

Treatment:

Procedure: Phase contrast flow velocity mapping (PC)

Procedure: Dynamic contrast-enhanced magnetic resonance imaging

Pulmonary Patients

Experimental group

Description:

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

Treatment:

Procedure: Phase contrast flow velocity mapping (PC)

Procedure: Dynamic contrast-enhanced magnetic resonance imaging