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Clinical Trials/NCT05476653
NCT05476653UnknownNot Applicable

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

Hopital Foch1 site in 1 country50 target enrollmentStarted: November 3, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
50
Locations
1
Primary Endpoint
To assess the bronchial lesions

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

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.

Intervention: MRI procedure (Other)

Outcomes

Primary Outcomes

To assess the bronchial lesions

Time Frame: 6 montths

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

Time Frame: 6 montths

Analysis of the presence and lobar distribution of hypoperfused pulmonary areas

Secondary Outcomes

  • To assess the MRI results versus the scanner results(6 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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