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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01192360
• Other study ID #: 1000016503
• Status: Completed
• Phase: Phase 3
• Start date: September 2010
• Est. completion date: December 2012

Study information

• Verified date: July 2019
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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®.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Cystic Fibrosis
• Fibrosis
• Heart Defects, Congenital
• Heart Disease
• Heart Diseases
• Lung Diseases

Intervention

Procedure:
• 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.
• 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.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulmonary blood flow	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.	1 hour
Secondary	Perfusion defects detected	Perfusion defects (number and location) will be compared to images of lung morphology and correlated with pathology within the lung parenchyma and central airways.	1 hour
Secondary	Quantitative results from dynamic contrast-enhanced magnetic resonance perfusion imaging	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.	1 hour