ABPA-MR: Diagnostic Value of MRI for Allergic Broncho-Pulmonary Aspergilloses

Sponsor
University Hospital, Bordeaux (Other)
Overall Status
Completed
CT.gov ID
NCT03265366
Collaborator
(none)
25
1
2
28.3
0.9

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
  • Device: MRI
  • Device: CT scan (standard reference)
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
25 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Diagnostic Value of MRI for Allergic Broncho-Pulmonary Aspergilloses
Actual Study Start Date :
Sep 14, 2017
Actual Primary Completion Date :
Jan 24, 2020
Actual Study Completion Date :
Jan 24, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: ABPA

15 patients with ABPA

Device: MRI
It will be performed on a 1.5-Tesla MR scanner (MAGNETOM Avanto, Siemens Healthcare, Erlangen, Germany), without injection or inhalation of contrast agent.

Device: CT scan (standard reference)
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

Device: MRI
It will be performed on a 1.5-Tesla MR scanner (MAGNETOM Avanto, Siemens Healthcare, Erlangen, Germany), without injection or inhalation of contrast agent.

Device: CT scan (standard reference)
It will be performed on a 16 (Sensation 16, Siemens®) or 64 channels (Definition 64, Siemens®), without contrast agent injection.

Outcome Measures

Primary Outcome Measures

  1. Concordance between chest CT scan and MRI for bronchial and pulmonary signs of ABPA (bronchiectases, infiltrates, impactions) [Day 0]

    Measured by a kappa test

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU de Bordeaux Pessac France 33604

Sponsors and Collaborators

  • University Hospital, Bordeaux

Investigators

  • Principal Investigator: Julie MACEY, MD, University Hospital, Bordeaux

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT03265366
Other Study ID Numbers:
  • CHUBX 2016/12
First Posted:
Aug 29, 2017
Last Update Posted:
Feb 10, 2022
Last Verified:
Feb 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Bordeaux
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 10, 2022