Primary Immune DeficiencyIRMvsSCANNERNCT05476653
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) .
A study testing MRI procedure in people with Primary Immune Deficiency, run by Hopital Foch at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Immune Deficiency
- What is being tested?
- MRI procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 3 Nov 2021to May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Foch hospital
Suresnes, 92151
Louis-jean Couderc, MD, 0146252315, lj.couderc@hopital-foch.com
Philippe Grenier, MD, 0146253635 ext. +33, p.grenier@hopital-foch.com
About this study
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
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:
Read more
- 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
- Being tested
- MRI procedure
- Keywords
- Primary Immune Deficiency, MRI, Chest CT Scan
- Medical subject headings
- Primary Immunodeficiency Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI procedureOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: MRI procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 montths
To assess the parenchymal lesions
Analysis of the presence and lobar distribution of hypoperfused pulmonary areas
Measured: 6 montths
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start3 Nov 2021
- Primary completionNov 2022 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Immune DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Collaborators
- Siemens Healthcare QT
- Responsible party
- Sponsor
- Investigators
- 0146252315 Louis-Jean Couderc,MD, Principal investigator, lj.couderc@hopitalfoch.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05476653
- Sponsor's protocol ID
- 2021_0015
- Acronym
- IRMvsSCANNER
- Status last verified
- Jul 2022
- First submitted
- 31 Jan 2022
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05476653
- Acronym / sponsor ID
- IRMvsSCANNER / 2021_0015
- Conditions
- Primary Immune Deficiency
- Keywords
- Primary Immune Deficiency, MRI, Chest CT Scan
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Collaborators
- Siemens Healthcare QT
- Study start
- 3 Nov 2021 (actual)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 27 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MRI exam | Experimental | Other: MRI procedurePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- Pregnant woman
- Contraindications to MRI:
- To be deprived of liberty or under guardianship.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI procedurePulmonary 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. | Other | MRI exam |
Primary outcome
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
1 secondary outcome
To assess the MRI results versus the scanner results
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
0146252315 Louis-Jean Couderc,MD principal investigator
lj.couderc@hopitalfoch.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI procedure in people with Primary Immune Deficiency, run by Hopital Foch at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elisabeth Hulier-Ammar,PHD (0146251175 ext. +33, drci-promotion@hopital-foch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the bronchial lesions (time frame: 6 montths). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2022; AzTrials last refreshed its copy on 7 Nov 2026.