We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2010 by The Hospital for Sick Children.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01192360
First Posted: September 1, 2010
Last Update Posted: September 16, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
The Hospital for Sick Children
  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
Intervention Model: Parallel Assignment
Masking: None (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 ]
    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 ]
    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 ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: August 30, 2010
First Posted: September 1, 2010
Last Update Posted: September 16, 2010
Last Verified: September 2010

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

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