Lung DiseasesIRM-EPNCT01077778
Magnetic Resonance Diagnosis of Pulmonary Embolism
An observational study of Lung Diseases and Pulmonary Embolism, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The purpose of this study is to evaluate the diagnostic accuracy of thoracic magnetic resonance imaging with gadolinium-enhanced, unenhanced and perfusion sequences in patients with clinically suspected acute pulmonary embolism Thoracic CT angiography (CTA) will serve as reference standard Result of MRI will not… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Diseases, Pulmonary Embolism
- What is being tested?
- Gadolinium-enhanced Magnetic Resonance Imaging
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2007to Feb 2010
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with acute pulmonary embolism suspicion who fulfil the inclusion criteria
Who may be able to join
- Clinically suspected acute pulmonary embolism
- 18 years old or more
- D-dimers more than 500 or high clinical probability of pulmonary embolism according to the revised Geneva score
- Thoracic CT angiography performed within 24 hours
- Informed consent
Who cannot join
- - Contraindication to MRI (pace maker, claustrophobia, any implanted ferromagnetic foreign body)
- Obese patients too large to fit in MRI unit
- Allergy to gadolinium-containing contrast agent or to iodinated contrast media
- Renal insufficiency (clearance less than 30 ml/mn)
- Anticoagulation at a curative dose started more than 48 hours prior to MRI
- Life expectancy less than 3 months
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Magnetic Resonance Diagnosis of Pulmonary Embolism: Prospective Evaluation in 280 Patients, With Comparison to Multi-slice CT Angiography
- The purpose of this study is to evaluate the diagnostic accuracy of thoracic magnetic resonance imaging with gadolinium-enhanced, unenhanced and perfusion sequences in patients with clinically suspected acute pulmonary embolism
- Thoracic CT angiography (CTA) will serve as reference standard
- Result of MRI will not interfere with patients' management
- Untreated patients with negative CTA will have 3-month follow-up to verify they were free of thrombose-embolic disease
Read the detailed description
Background In patients with clinically suspected pulmonary embolism (PE)°with a contraindication to thoracic CT angiography, there is a need for an alternative diagnostic procedure. MRI has not been fully evaluated in this field; moreover, recent technological advances make it necessary to re-evaluate its performance for PE diagnosis.
Design Prospective monocentric study
- Patients with clinically suspected acute pulmonary embolism will undergo thoracic magnetic resonance imaging if inclusion criteria are fulfilled.
- A non-inclusion register will be establish for patients fulfilling the inclusion criteria , not included because MRI was not available (off-hours presentation , another patients already included in the protocol on the same day )
Estimated enrolment : 280 (based on a 25% prevalence of PE in our institution and an expected 80% sensitivity of MRI) Study start date: June 2007 Estimated study completion date: 17 months later (40 to 50 presentations for PE suspicion each month, 20 inclusions expected per month)
Magnetic Resonance imaging: performed on a 1.5 Tesla unit with 3 different sequences
- Unenhanced Steady State Free Precession (SSFP) sequences
- Perfusion imaging following Gadolinium injection at a rate of 5 c/s and a dose of 0.1mmol/kg
- Magnetic resonance angiography following an injection of 0.1mmol/kg of gadolinium at 3ml/s MRI studies will be interpreted secondarily by 2 independent radiologists, blinded to CTA results and clinical probability.
Two different readings will be performed, one global reading and one reading of each sequence separately, displayed in a random order (access base)
Objectives
- to evaluate MRI performance for PE diagnosis globally
- to evaluate the diagnostic value for each sequence (especially the negative predictive value of a normal perfusion sequence)
- to evaluate inter-observer agreement
MRI and CTA have to be performed within 24 hours
- Conditions
- Lung Diseases, Pulmonary Embolism
- Being tested
- Gadolinium-enhanced Magnetic Resonance Imaging
- Keywords
- Magnetic Resonance Imaging/methods, Magnetic Resonance Angiography, Perfusion Imaging, Pulmonary Embolism/diagnosis
- Medical subject headings
- Lung Diseases, Pulmonary Embolism, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gadolinium-enhanced Magnetic Resonance ImagingProcedure or surgery
Gadolinium-enhanced Magnetic Resonance Imaging
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI studies will be interpreted at the end of the inclusion process. CTA results will serve as reference standard to evaluate MRI sensitivity, specificity, positive and negative predictive values. Inter-observer agreement will be evaluated
Measured: 17 months after the first inclusion
Secondary outcomes (1)
3 months clinical follow-up will be performed in patients with negative CTA results who did not receive anticoagulation. This is to verify there were no false negatives on CTA
Measured: 3 months afer CTA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2010 (estimated)
- Study startMar 2007
- Primary completionSep 2007
- Study completionFeb 2010
Why it stopped: the number of patients will be included is reach
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Investigators
- Marie-pierre Revel, PH, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01077778
- Sponsor's protocol ID
- P051068
- Acronym
- IRM-EP
- Status last verified
- Mar 2007
- First submitted
- 26 Feb 2010
- Last updated
- 25 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Blum A, Bellou A, Guillemin F, Douek P, Laprevote-Heully MC, Wahl D; GENEPI study group. Performance of magnetic resonance angiography in suspected acute pulmonary embolism. Thromb Haemost. 2005 Mar;93(3):503-11. doi: 10.1160/TH04-08-0495.
PubMed 15735802Pleszewski B, Chartrand-Lefebvre C, Qanadli SD, Dery R, Perreault P, Oliva VL, Prenovault J, Belblidia A, Soulez G. Gadolinium-enhanced pulmonary magnetic resonance angiography in the diagnosis of acute pulmonary embolism: a prospective study on 48 patients. Clin Imaging. 2006 May-Jun;30(3):166-72. doi: 10.1016/j.clinimag.2005.10.005.
PubMed 16632150Revel MP, Sanchez O, Lefort C, Meyer G, Couchon S, Hernigou A, Niarra R, Chatellier G, Frija G. Diagnostic accuracy of unenhanced, contrast-enhanced perfusion and angiographic MRI sequences for pulmonary embolism diagnosis: results of independent sequence readings. Eur Radiol. 2013 Sep;23(9):2374-82. doi: 10.1007/s00330-013-2852-8. Epub 2013 May 8.
PubMed 23652845
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance Diagnosis of Pulmonary Embolism: Prospective Evaluation in 280 Patients, With Comparison to Multi-slice CT Angiography
- ClinicalTrials.gov ID
- NCT01077778
- Acronym / sponsor ID
- IRM-EP / P051068
- Conditions
- Lung Diseases, Pulmonary Embolism
- Keywords
- Magnetic Resonance Imaging/methods, Magnetic Resonance Angiography, Perfusion Imaging, Pulmonary Embolism/diagnosis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: the number of patients will be included is reach
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Mar 2007
- Primary completion
- Sep 2007 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 1 Mar 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 purpose of this study is to evaluate the diagnostic accuracy of thoracic magnetic resonance imaging with gadolinium-enhanced, unenhanced and perfusion sequences in patients with clinically suspected acute pulmonary embolism
- Thoracic CT angiography (CTA) will serve as reference standard
- Result of MRI will not interfere with patients' management
- Untreated patients with negative CTA will have 3-month follow-up to verify they were free of thrombose-embolic disease
Detailed description
Background In patients with clinically suspected pulmonary embolism (PE)°with a contraindication to thoracic CT angiography, there is a need for an alternative diagnostic procedure. MRI has not been fully evaluated in this field; moreover, recent technological advances make it necessary to re-evaluate its performance for PE diagnosis.
Design Prospective monocentric study
- Patients with clinically suspected acute pulmonary embolism will undergo thoracic magnetic resonance imaging if inclusion criteria are fulfilled.
- A non-inclusion register will be establish for patients fulfilling the inclusion criteria , not included because MRI was not available (off-hours presentation , another patients already included in the protocol on the same day )
Estimated enrolment : 280 (based on a 25% prevalence of PE in our institution and an expected 80% sensitivity of MRI) Study start date: June 2007 Estimated study completion date: 17 months later (40 to 50 presentations for PE suspicion each month, 20 inclusions expected per month)
Magnetic Resonance imaging: performed on a 1.5 Tesla unit with 3 different sequences
- Unenhanced Steady State Free Precession (SSFP) sequences
- Perfusion imaging following Gadolinium injection at a rate of 5 c/s and a dose of 0.1mmol/kg
- Magnetic resonance angiography following an injection of 0.1mmol/kg of gadolinium at 3ml/s MRI studies will be interpreted secondarily by 2 independent radiologists, blinded to CTA results and clinical probability.
Two different readings will be performed, one global reading and one reading of each sequence separately, displayed in a random order (access base)
Objectives
- to evaluate MRI performance for PE diagnosis globally
- to evaluate the diagnostic value for each sequence (especially the negative predictive value of a normal perfusion sequence)
- to evaluate inter-observer agreement
MRI and CTA have to be performed within 24 hours
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with acute pulmonary embolism suspicion who fulfil the inclusion criteria
Key inclusion criteria (5 listed)
- Clinically suspected acute pulmonary embolism
- 18 years old or more
- D-dimers more than 500 or high clinical probability of pulmonary embolism according to the revised Geneva score
- Thoracic CT angiography performed within 24 hours
- Informed consent
Key exclusion criteria (7 listed)
- - Contraindication to MRI (pace maker, claustrophobia, any implanted ferromagnetic foreign body)
- Obese patients too large to fit in MRI unit
- Allergy to gadolinium-containing contrast agent or to iodinated contrast media
- Renal insufficiency (clearance less than 30 ml/mn)
- Anticoagulation at a curative dose started more than 48 hours prior to MRI
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 |
|---|---|---|
| Gadolinium-enhanced Magnetic Resonance ImagingGadolinium-enhanced Magnetic Resonance Imaging | Procedure or surgery | – |
Primary outcome
MRI studies will be interpreted at the end of the inclusion process. CTA results will serve as reference standard to evaluate MRI sensitivity, specificity, positive and negative predictive values. Inter-observer agreement will be evaluated
Time frame: 17 months after the first inclusion
1 secondary outcome
3 months clinical follow-up will be performed in patients with negative CTA results who did not receive anticoagulation. This is to verify there were no false negatives on CTA
Time frame: 3 months afer CTA
Results and safety
The study was stopped early (reason given: the number of patients will be included is reach). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2016.
- Background: PubMed 15735802Blum A, Bellou A, Guillemin F, Douek P, Laprevote-Heully MC, Wahl D; GENEPI study group. Performance of magnetic resonance angiography in suspected acute pulmonary embolism. Thromb Haemost. 2005 Mar;93(3):503-11. doi: 10.1160/TH04-08-0495.
- Background: PubMed 16632150Pleszewski B, Chartrand-Lefebvre C, Qanadli SD, Dery R, Perreault P, Oliva VL, Prenovault J, Belblidia A, Soulez G. Gadolinium-enhanced pulmonary magnetic resonance angiography in the diagnosis of acute pulmonary embolism: a prospective study on 48 patients. Clin Imaging. 2006 May-Jun;30(3):166-72. doi: 10.1016/j.clinimag.2005.10.005.
- Derived from this study: PubMed 23652845Revel MP, Sanchez O, Lefort C, Meyer G, Couchon S, Hernigou A, Niarra R, Chatellier G, Frija G. Diagnostic accuracy of unenhanced, contrast-enhanced perfusion and angiographic MRI sequences for pulmonary embolism diagnosis: results of independent sequence readings. Eur Radiol. 2013 Sep;23(9):2374-82. doi: 10.1007/s00330-013-2852-8. Epub 2013 May 8.
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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.
Marie-pierre Revel, PH principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Diseases and Pulmonary Embolism, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 5 inclusion and 7 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: stopped early, as of the sponsor's last update on 25 Jan 2016. 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 France. 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.
Are results available for this study?
The study was stopped early (reason given: the number of patients will be included is reach). Results are not available in the source record.
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?
MRI studies will be interpreted at the end of the inclusion process. CTA results will serve as reference standard to evaluate MRI sensitivity, specificity, positive and negative predictive values. Inter-observer agreement will be evaluated (time frame: 17 months after the first inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01077778, which also lists 3 linked publications.
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 25 Jan 2016.