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) .

NCT ID: NCT05476653

Last Updated: 2022-07-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-03

Study Completion Date

2023-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Primary Immune Deficiency

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

MRI exam

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.

Group Type EXPERIMENTAL

MRI procedure

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Siemens Healthcare QT

INDUSTRY

Sponsor Role collaborator

Hopital Foch

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

0146252315 Louis-Jean Couderc,MD

Role: PRINCIPAL_INVESTIGATOR

[email protected]

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Foch hospital

Suresnes, , France

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

France

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Elisabeth Hulier-Ammar,PHD

Role: CONTACT

0146251175 ext. +33

Virginie Guitard

Role: CONTACT

0146257388 ext. +33

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Louis-jean Couderc, MD

Role: primary

0146252315

Philippe Grenier, MD

Role: backup

0146253635 ext. +33

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2021_0015

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

PET-CT in Lymphoma Among the Eldery
NCT07259941 NOT_YET_RECRUITING