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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by The Hospital for Sick Children.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT01192360
First received: August 30, 2010
Last updated: September 14, 2010
Last verified: September 2010
  Purpose

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.


Condition Intervention Phase
Heart Disease
Cystic Fibrosis
Asthma
Procedure: Phase contrast flow velocity mapping (PC)
Procedure: Dynamic contrast-enhanced magnetic resonance imaging
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Dynamic Contrast Enhanced Magnetic Resonance Perfusion Imaging in Congenital Heart Disease and Lung Disease

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Pulmonary blood flow [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 50
Study Start Date: September 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cardiac Patients 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.
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.
Experimental: Pulmonary Patients 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.
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.

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®.

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01192360

Contacts
Contact: Lars Grosse-Wortmann, MD 416-813-7308 lars.grosse-wortmann@sickkids.ca

Locations
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Lars Grosse-Wortmann, MD    416 813 7308    lars.grosse-wortmann@sickkids.ca   
Principal Investigator: Lars Grosse-Wortmann, MD         
Sub-Investigator: Joshua van Amerom, MD         
Sub-Investigator: Hartmut Grasemann, MD         
Sub-Investigator: Shi-Joon Yoo, MD         
Sub-Investigator: Christopher Macgowan, PhD         
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Lars Grosse-Wortmann, MD The Hospital for Sick Children, Toronto Canada
  More Information

No publications provided

Responsible Party: Dr. Lars Grosse-Wortmann / Principal Investigator, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT01192360     History of Changes
Other Study ID Numbers: 1000016503
Study First Received: August 30, 2010
Last Updated: September 14, 2010
Health Authority: Canada: Health Canada

Keywords provided by The Hospital for Sick Children:
pediatrics
Heart Disease
Cystic Fibrosis
Severe Asthma
Magnetic Resonance Imaging

Additional relevant MeSH terms:
Asthma
Cystic Fibrosis
Fibrosis
Heart Diseases
Lung Diseases
Heart Defects, Congenital
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pancreatic Diseases
Digestive System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pathologic Processes
Cardiovascular Diseases
Cardiovascular Abnormalities
Congenital Abnormalities

ClinicalTrials.gov processed this record on August 25, 2014