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

NCT01192360 | Completed Phase 3

• 1 other identifier: 1000016503
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Disease; Cystic Fibrosis; Asthma

Keywords

pediatrics; Heart Disease; Cystic Fibrosis; Severe Asthma; Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Perfusion defects detected

  1 hour

• Quantitative results from dynamic contrast-enhanced magnetic resonance perfusion imaging

  1 hour

Study Arms (2)

Cardiac Patients

EXPERIMENTAL

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.

Procedure: Phase contrast flow velocity mapping (PC); Procedure: Dynamic contrast-enhanced magnetic resonance imaging

Pulmonary Patients

EXPERIMENTAL

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

Procedure: Phase contrast flow velocity mapping (PC); Procedure: Dynamic contrast-enhanced magnetic resonance imaging

Interventions

Phase contrast flow velocity mapping (PC) 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.

Cardiac Patients; Pulmonary Patients

Dynamic contrast-enhanced magnetic resonance imaging 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.

Cardiac Patients; Pulmonary Patients

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Heart Diseases; Cystic Fibrosis; Asthma

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Lars Grosse-Wortmann, MD

  The Hospital for Sick Children, Toronto Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 30, 2010
• First Posted: September 1, 2010
• Study Start: September 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: July 5, 2019

Record last verified: 2019-07

Locations

CA (1)