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) .

Primary Immune Deficiency Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05476653
• Other study ID #: 2021_0015
• Status: Recruiting
• Phase: N/A
• Start date: November 3, 2021
• Est. completion date: May 2023

Study information

• Verified date: July 2022
• Source: Hopital Foch
• Contact: Elisabeth Hulier-Ammar,PHD
• Phone: 0146251175
• Email: drci-promotion[@]hopital-foch.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 2023
• Est. primary completion date: November 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Immunologic Deficiency Syndromes
• Primary Immune Deficiency
• Primary Immunodeficiency Diseases

Intervention

Other:
• 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.

Locations

Country	Name	City	State
France	Foch hospital	Suresnes

Sponsors (2)

Lead Sponsor	Collaborator
Hopital Foch	Siemens Healthcare QT

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 montths
Primary	To assess the parenchymal lesions	Analysis of the presence and lobar distribution of hypoperfused pulmonary areas	6 montths
Secondary	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.	6 months