Back to resultsDynamic Contrast Enhanced Magnetic Resonance Perfusion Imaging in Congenital Heart Disease and Lung Disease
Primary Purpose
Heart Disease, Cystic Fibrosis, Asthma
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Phase contrast flow velocity mapping (PC)
Dynamic contrast-enhanced magnetic resonance imaging
Sponsored by
About this trial
This is an interventional treatment trial for Heart Disease focused on measuring pediatrics, Heart Disease, Cystic Fibrosis, Severe Asthma, Magnetic Resonance Imaging
Eligibility Criteria
Inclusion Criteria:
Cardiac Patients:
- Patients > 6 years of age
- Patients with suspected or confirmed congenital or acquired heart disease
- Who undergo a clinically indicated MRI scan, including gadolinium (MRI contrast medium)
- And receive gadolinium (= MRI contrast medium) as part of their clinical investigation
Pulmonary Patients:
- Patients > 6 years of age
- Patients with a chronic and stable lung condition, such as cystic fibrosis, severe asthma.
Exclusion Criteria:
- Children under the age of 6 will be excluded as they are routinely scanned under general anesthesia
- Patients in whom MRI is contraindicated (e.g. pacemaker, ocular metal, claustrophobia, tattoos)
- Patients with a known allergy to gadolinium.
- Patients with a history of allergic disposition or have anaphylactic reactions
- Moderate-to-severe renal impairment (defined as having a GFR/ eGFR < 60 mL/min)
- Have Sickle Cell anemia
- Known pregnancy, or breast feeding
- Patient is uncooperative during a MRI without sedation or anesthesia
Sites / Locations
- The Hospital for Sick Children
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Cardiac Patients
Pulmonary Patients
Arm 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.
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT01192360
First Posted
August 30, 2010
Last Updated
July 2, 2019
Sponsor
The Hospital for Sick Children
1. Study Identification
Unique Protocol Identification Number
NCT01192360
Brief Title
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
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children
4. Oversight
Data Monitoring Committee
No
5. Study Description
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®.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Disease, Cystic Fibrosis, Asthma
Keywords
pediatrics, Heart Disease, Cystic Fibrosis, Severe Asthma, Magnetic Resonance Imaging
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cardiac Patients
Arm Type
Experimental
Arm 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.
Arm Title
Pulmonary Patients
Arm Type
Experimental
Arm 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
Intervention Type
Procedure
Intervention Name(s)
Phase contrast flow velocity mapping (PC)
Intervention Description
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
Intervention Name(s)
Dynamic contrast-enhanced magnetic resonance imaging
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pulmonary blood flow
Description
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.
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Perfusion defects detected
Description
Perfusion defects (number and location) will be compared to images of lung morphology and correlated with pathology within the lung parenchyma and central airways.
Time Frame
1 hour
Title
Quantitative results from dynamic contrast-enhanced magnetic resonance perfusion imaging
Description
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.
Time Frame
1 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Cardiac Patients:
Patients > 6 years of age
Patients with suspected or confirmed congenital or acquired heart disease
Who undergo a clinically indicated MRI scan, including gadolinium (MRI contrast medium)
And receive gadolinium (= MRI contrast medium) as part of their clinical investigation
Pulmonary Patients:
Patients > 6 years of age
Patients with a chronic and stable lung condition, such as cystic fibrosis, severe asthma.
Exclusion Criteria:
Children under the age of 6 will be excluded as they are routinely scanned under general anesthesia
Patients in whom MRI is contraindicated (e.g. pacemaker, ocular metal, claustrophobia, tattoos)
Patients with a known allergy to gadolinium.
Patients with a history of allergic disposition or have anaphylactic reactions
Moderate-to-severe renal impairment (defined as having a GFR/ eGFR < 60 mL/min)
Have Sickle Cell anemia
Known pregnancy, or breast feeding
Patient is uncooperative during a MRI without sedation or anesthesia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lars Grosse-Wortmann, MD
Organizational Affiliation
The Hospital for Sick Children, Toronto Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
12. IPD Sharing Statement
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Dynamic Contrast Enhanced Magnetic Resonance Perfusion Imaging in Congenital Heart Disease and Lung Disease
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