- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03265366
Diagnostic Value of MRI for Allergic Broncho-Pulmonary Aspergilloses (ABPA-MR)
May 11, 2026 updated by: University Hospital, Bordeaux
The aim of the study is to compare the concordance between chest computerized tomography-scan (CTscan) and Magnetic resonance Imaging (MRI) for the description of the abnormalities seen in Allergic BronchoPulmonary Aspergillosis (ABPA).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The ABPA is responsible for pulmonary exacerbations in chronic bronchial diseases.
The treatment of ABPA consists in systemic corticosteroids and anti fungal therapy, which can have severe side effects.
The diagnosis is difficult, based on several but non-specific characteristics.
One of the radiologic abnormalities on CTscan could be more specific : high attenuation in impacted mucus, but this sign is found in about 30% of cases.
Recent articles and investigators experience seem to demonstrate that MRI could provide an interesting tool for ABPA diagnosis, studying the signal of bronchial impactions.
The aim of the study is to describe the MRI characteristics of patients with ABPA and compare the results with those obtained by CTscan, and in order to determine if there is a specific signal of impaction in ABPA.
Study Type
Interventional
Enrollment (Actual)
25
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Pessac, France, 33604
- Chu de Bordeaux
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- study patients have a diagnosis of ABPA
- control patients have severe asthma
- All the patients are ≥ 18 years old, have social security care, signature of consent form
Exclusion Criteria:
- cystic fibrosis
- other type of aspergilloses
- contraindication for MRI
- woman without effective contraception
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ABPA
15 patients with ABPA
|
It will be performed on a 1.5-Tesla MR scanner (MAGNETOM Avanto, Siemens Healthcare, Erlangen, Germany), without injection or inhalation of contrast agent.
It will be performed on a 16 (Sensation 16, Siemens®) or 64 channels (Definition 64, Siemens®), without contrast agent injection.
|
|
Active Comparator: Severe asthma
12 patients with severe asthma
|
It will be performed on a 1.5-Tesla MR scanner (MAGNETOM Avanto, Siemens Healthcare, Erlangen, Germany), without injection or inhalation of contrast agent.
It will be performed on a 16 (Sensation 16, Siemens®) or 64 channels (Definition 64, Siemens®), without contrast agent injection.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Concordance between chest CT scan and MRI for bronchial and pulmonary signs of ABPA (bronchiectases, infiltrates, impactions)
Time Frame: Day 0
|
Measured by a kappa test
|
Day 0
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Julie MACEY, MD, University Hospital, Bordeaux
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 14, 2017
Primary Completion (Actual)
January 24, 2020
Study Completion (Actual)
January 24, 2020
Study Registration Dates
First Submitted
August 25, 2017
First Submitted That Met QC Criteria
August 25, 2017
First Posted (Actual)
August 29, 2017
Study Record Updates
Last Update Posted (Actual)
May 14, 2026
Last Update Submitted That Met QC Criteria
May 11, 2026
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Respiratory Tract Infections
- Infections
- Respiratory Tract Diseases
- Lung Diseases
- Respiratory Hypersensitivity
- Hypersensitivity, Immediate
- Hypersensitivity
- Bacterial Infections and Mycoses
- Lung Diseases, Fungal
- Mycoses
- Pulmonary Aspergillosis
- Aspergillosis
- Aspergillosis, Allergic Bronchopulmonary
- Investigative Techniques
- Diagnostic Techniques and Procedures
- Diagnosis
- Tomography
- Diagnostic Imaging
- Radiography
- Image Interpretation, Computer-Assisted
- Radiographic Image Enhancement
- Image Enhancement
- Photography
- Tomography, X-Ray
- Weights and Measures
- Tomography, X-Ray Computed
- Reference Standards
Other Study ID Numbers
- CHUBX 2016/12
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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