Heart DiseasePhase 3NCT01192360
Dynamic Contrast Enhanced Magnetic Resonance Perfusion Imaging in Congenital Heart Disease and Lung Disease
A Phase 3 study testing Phase contrast flow velocity mapping (PC) and Dynamic contrast-enhanced magnetic resonance imaging in people with Heart Disease and Cystic Fibrosis, run by The Hospital for Sick Children at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Heart Disease, Cystic Fibrosis, Asthma
- What is being tested?
- Phase contrast flow velocity mapping (PC) and Dynamic contrast-enhanced magnetic resonance imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2010to Dec 2012
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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®.
- Conditions
- Heart Disease, Cystic Fibrosis, Asthma
- Being tested
- Phase contrast flow velocity mapping (PC), Dynamic contrast-enhanced magnetic resonance imaging
- Keywords
- pediatrics, Heart Disease, Cystic Fibrosis, Severe Asthma, Magnetic Resonance Imaging
- Medical subject headings
- Heart Diseases, Cystic Fibrosis, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase contrast flow velocity mapping (PC)Procedure or surgery
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 imagingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Procedure: Phase contrast flow velocity mapping (PC); Procedure: Dynamic contrast-enhanced magnetic resonance imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour
Secondary outcomes (2)
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.
Measured: 1 hour
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.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart DiseaseStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lars Grosse-Wortmann, The Hospital for Sick Children
- Investigators
- Lars Grosse-Wortmann, MD, Principal investigator, The Hospital for Sick Children, Toronto Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01192360
- Sponsor's protocol ID
- 1000016503
- Status last verified
- Jul 2019
- First submitted
- 30 Aug 2010
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Contrast Enhanced Magnetic Resonance Perfusion Imaging in Congenital Heart Disease and Lung Disease
- ClinicalTrials.gov ID
- NCT01192360
- Acronym / sponsor ID
- 1000016503
- Conditions
- Heart Disease, Cystic Fibrosis, Asthma
- Keywords
- pediatrics, Heart Disease, Cystic Fibrosis, Severe Asthma, Magnetic Resonance Imaging
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 1 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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®.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiac Patients | Experimental | Procedure: Phase contrast flow velocity mapping (PC), Procedure: Dynamic contrast-enhanced magnetic resonance imagingIn 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. |
| Pulmonary Patients | Experimental | Procedure: Phase contrast flow velocity mapping (PC), Procedure: Dynamic contrast-enhanced magnetic resonance imagingPatients 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 |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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
- Patients > 6 years of age
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 or surgery | Cardiac Patients, Pulmonary Patients |
| Dynamic contrast-enhanced magnetic resonance imagingDynamic 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. | Procedure or surgery | Cardiac Patients, Pulmonary Patients |
Primary outcome
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.
2 secondary outcomes
Perfusion defects detected
Time frame: 1 hour
Quantitative results from dynamic contrast-enhanced magnetic resonance perfusion imaging
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars Grosse-Wortmann, MD principal investigator
The Hospital for Sick Children, Toronto Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Phase contrast flow velocity mapping (PC) and Dynamic contrast-enhanced magnetic resonance imaging in people with Heart Disease and Cystic Fibrosis, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary blood flow (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.