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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)

H

Hopital Foch

Status

Enrolling

Conditions

Primary Immune Deficiency

Treatments

Other: MRI procedure

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT05476653
2021_0015

Details and patient eligibility

About

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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

MRI exam
Experimental group
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.
Treatment:
Other: MRI procedure

Trial contacts and locations

1

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Central trial contact

Elisabeth Hulier-Ammar,PHD; Virginie Guitard

Data sourced from clinicaltrials.gov

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