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) .

NCT05476653 | Unknown

• 1 other identifier: 2021_0015
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Immune Deficiency

Keywords

Primary Immune Deficiency; MRI; Chest CT Scan

Outcome Measures

Primary Outcomes (2)

• 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

• To assess the parenchymal lesions

  Analysis of the presence and lobar distribution of hypoperfused pulmonary areas

  6 montths

Secondary Outcomes (1)

• To assess the MRI results versus the scanner results

  6 months

Study Arms (1)

MRI exam

EXPERIMENTAL

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.

Other: MRI procedure

Interventions

MRI procedure OTHER

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.

MRI exam

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hopital Foch: lead
• Siemens Healthcare QT: collaborator

Study Sites (1)

Foch hospital

Suresnes, 92151, France

RECRUITING

MeSH Terms

Conditions

Primary Immunodeficiency Diseases

Condition Hierarchy (Ancestors)

Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• 0146252315 Louis-Jean Couderc,MD

  lj.couderc@hopitalfoch.com

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisabeth Hulier-Ammar,PHD

CONTACT

0146251175; drci-promotion@hopital-foch.com

Virginie Guitard

CONTACT

0146257388; v.guitard@hopital-foch.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: July 27, 2022
• Study Start: November 3, 2021
• Primary Completion: November 1, 2022
• Study Completion: May 1, 2023
• Last Updated: July 27, 2022

Record last verified: 2022-07

Locations

FR (1)