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

NCT ID: NCT01192360

Last Updated: 2019-07-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2012-12-31

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®.

Conditions

Heart Disease; Cystic Fibrosis; Asthma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cardiac Patients

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.

Group Type: EXPERIMENTAL

Phase contrast flow velocity mapping (PC)

Intervention Type: PROCEDURE

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.

Dynamic contrast-enhanced magnetic resonance imaging

Intervention Type: PROCEDURE

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.

Pulmonary Patients

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

Group Type: EXPERIMENTAL

Phase contrast flow velocity mapping (PC)

Intervention Type: PROCEDURE

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.

Dynamic contrast-enhanced magnetic resonance imaging

Intervention Type: PROCEDURE

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.

Interventions

Phase 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.

Intervention Type: PROCEDURE

Dynamic 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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Lars Grosse-Wortmann

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lars Grosse-Wortmann, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children, Toronto Canada

Locations

The Hospital for Sick Children

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

1000016503

Identifier Type: -

Identifier Source: org_study_id