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) . (IRMvsSCANNER)
Primary Purpose
Primary Immune Deficiency
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI procedure
Sponsored by
About this trial
This is an interventional other trial for Primary Immune Deficiency focused on measuring Primary Immune Deficiency, MRI, Chest CT Scan
Eligibility Criteria
Inclusion Criteria:
- Patients aged 18 or over
- 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:
- Pregnant woman
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.
Sites / Locations
- Foch hospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MRI exam
Arm Description
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.
Outcomes
Primary Outcome Measures
To assess the bronchial lesions
Analysis of the presence, the severity (cylindrical, varicose or cystic) and segmental distribution of bronchiectasis, 2. the presence and lobar distribution of hypoperfused pulmonary areas, and 3. the presence and lobar distribution of interstitial abnormality and pulmonary nodular lesions.
Those three components will be independently identified by lung scanners and MRIs.
To assess the parenchymal lesions
Analysis of the presence and lobar distribution of hypoperfused pulmonary areas
Secondary Outcome Measures
To assess the MRI results versus the scanner results
To assess the reproducibility of MRI performed using a prototype 3D-UTE SPIRALVIBE sequence and CT scan to detect bronchial and pulmonary parenchymal abnormalities at the segmental, lobar or pulmonary scale, by two independent thoracic radiologists.
Full Information
NCT ID
NCT05476653
First Posted
January 31, 2022
Last Updated
July 25, 2022
Sponsor
Hopital Foch
Collaborators
Siemens Healthcare QT
1. Study Identification
Unique Protocol Identification Number
NCT05476653
Brief Title
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) .
Acronym
IRMvsSCANNER
Official Title
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): IRM vs SCANNER
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 3, 2021 (Actual)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
May 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hopital Foch
Collaborators
Siemens Healthcare QT
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Currently, there is no official recommendations for the respiratory surveillance of patients with PID.However, it is recommended to perform a chest CT scan each 5 years or before any significant therapeutic change.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Immune Deficiency
Keywords
Primary Immune Deficiency, MRI, Chest CT Scan
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MRI exam
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
MRI procedure
Intervention Description
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.
Primary Outcome Measure Information:
Title
To assess the bronchial lesions
Description
Analysis of the presence, the severity (cylindrical, varicose or cystic) and segmental distribution of bronchiectasis, 2. the presence and lobar distribution of hypoperfused pulmonary areas, and 3. the presence and lobar distribution of interstitial abnormality and pulmonary nodular lesions.
Those three components will be independently identified by lung scanners and MRIs.
Time Frame
6 montths
Title
To assess the parenchymal lesions
Description
Analysis of the presence and lobar distribution of hypoperfused pulmonary areas
Time Frame
6 montths
Secondary Outcome Measure Information:
Title
To assess the MRI results versus the scanner results
Description
To assess the reproducibility of MRI performed using a prototype 3D-UTE SPIRALVIBE sequence and CT scan to detect bronchial and pulmonary parenchymal abnormalities at the segmental, lobar or pulmonary scale, by two independent thoracic radiologists.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients aged 18 or over
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:
Pregnant woman
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elisabeth Hulier-Ammar,PHD
Phone
0146251175
Ext
+33
Email
drci-promotion@hopital-foch.com
First Name & Middle Initial & Last Name or Official Title & Degree
Virginie Guitard
Phone
0146257388
Ext
+33
Email
v.guitard@hopital-foch.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
0146252315 Louis-Jean Couderc,MD
Organizational Affiliation
lj.couderc@hopitalfoch.com
Official's Role
Principal Investigator
Facility Information:
Facility Name
Foch hospital
City
Suresnes
ZIP/Postal Code
92151
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louis-jean Couderc, MD
Phone
0146252315
Email
lj.couderc@hopital-foch.com
First Name & Middle Initial & Last Name & Degree
Philippe Grenier, MD
Phone
0146253635
Ext
+33
Email
p.grenier@hopital-foch.com
12. IPD Sharing Statement
Learn more about this trial
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) .
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