A Prospective Monocentric Study to Assess the Concordance of Lung MRI Compared to Chest CT Scan to Assess the Extent and Severity of Bronchial and Parenchymal Pulmonary Lesions in Adult Patients With Primary Immune Deficiency (PID) .
NCT ID: NCT05476653
Last Updated: 2022-07-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2021-11-03
2023-05-31
Brief Summary
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The methods of surveillance need to meet two contradictory imperatives:
* monitor frequently enough not to diagnose with delay an aggravation of bronchiectasis or interstitial pneumonitis, an infectious complication by a slowly growing pathogen such as a non-tuberculous mycobacterium, or lymphoid proliferation.
* do not expose these often young patients to significant irradiation by a considerable number of scans during their life. In addition, some patients with PID have increased radiosensitivity without a safe irradiation threshold having been determined.
To make thoses requirements effective, the solution is to combine radiological monitoring and absence of irradiation. Therefore, it makes sense to study whether chest scans can be replaced by MRI, non-irradiating imaging. But the question that needs to be answered is whether the information provided by the chest MRI is not inferior to that provided by the scanner.
The objective of this study is to assess the ability of MRI performed with ultrashort echo time to analyze the extent and severity of bronchial and pulmonary parenchymal lesions during the follow-up of patients with primary immunodeficiency, comparing them to those of the chest CT scan.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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MRI exam
Patients will be asked to perform a pulmonary MRI in addition to the usual chest CT can.
The chest CT scan will be performed according to the usual protocol of standard practices. No difference is expected for this research protocol.
MRI procedure
Pulmonary MRI based on a 1.5 T machine (Siemens VIDA) or a 3T machine (Siemens SOLA) without the use of contrast product according to a protocol based on a 3D-UTE sequence acquired in free breathing but with a respiratory synchronization system in association with weightings in T1 and T2.
Interventions
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MRI procedure
Pulmonary MRI based on a 1.5 T machine (Siemens VIDA) or a 3T machine (Siemens SOLA) without the use of contrast product according to a protocol based on a 3D-UTE sequence acquired in free breathing but with a respiratory synchronization system in association with weightings in T1 and T2.
Eligibility Criteria
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Inclusion Criteria
* Adult patients with PID
* Patients who have performed EFR (Functional Respiratory Tests) within 6 months
* Patients who have signed a consent form
* Patients affiliated with a Health Insurance plan.
Exclusion Criteria
* Contraindications to MRI:
* Patients with magnetically activated implanted devices (cardiac pacemakers, insulin pumps, neurostimulators, cochlear implants),
* Patients with intraocular metal or in the brain (aneurysm clip),
* Patients with prostheses in the thoracic position and contraindicated for MRI examination
* Claustrophobic patients.
* To be deprived of liberty or under guardianship.
18 Years
ALL
No
Sponsors
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Siemens Healthcare QT
INDUSTRY
Hopital Foch
OTHER
Responsible Party
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Principal Investigators
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Locations
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Foch hospital
Suresnes, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2021_0015
Identifier Type: -
Identifier Source: org_study_id
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