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

Primary Purpose

Allergic Bronchopulmonary Aspergilloses

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI
CT scan (standard reference)
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Allergic Bronchopulmonary Aspergilloses focused on measuring Ultrashort echo time magnetic resonance imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Bordeaux

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

ABPA

Severe asthma

Arm Description

15 patients with ABPA

12 patients with severe asthma

Outcomes

Primary Outcome Measures

Concordance between chest CT scan and MRI for bronchial and pulmonary signs of ABPA (bronchiectases, infiltrates, impactions)
Measured by a kappa test

Secondary Outcome Measures

Full Information

First Posted
August 25, 2017
Last Updated
February 9, 2022
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT03265366
Brief Title
Diagnostic Value of MRI for Allergic Broncho-Pulmonary Aspergilloses
Acronym
ABPA-MR
Official Title
Diagnostic Value of MRI for Allergic Broncho-Pulmonary Aspergilloses
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
September 14, 2017 (Actual)
Primary Completion Date
January 24, 2020 (Actual)
Study Completion Date
January 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Bronchopulmonary Aspergilloses
Keywords
Ultrashort echo time magnetic resonance imaging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ABPA
Arm Type
Experimental
Arm Description
15 patients with ABPA
Arm Title
Severe asthma
Arm Type
Active Comparator
Arm Description
12 patients with severe asthma
Intervention Type
Device
Intervention Name(s)
MRI
Intervention Description
It will be performed on a 1.5-Tesla MR scanner (MAGNETOM Avanto, Siemens Healthcare, Erlangen, Germany), without injection or inhalation of contrast agent.
Intervention Type
Device
Intervention Name(s)
CT scan (standard reference)
Intervention Description
It will be performed on a 16 (Sensation 16, Siemens®) or 64 channels (Definition 64, Siemens®), without contrast agent injection.
Primary Outcome Measure Information:
Title
Concordance between chest CT scan and MRI for bronchial and pulmonary signs of ABPA (bronchiectases, infiltrates, impactions)
Description
Measured by a kappa test
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie MACEY, MD
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Bordeaux
City
Pessac
ZIP/Postal Code
33604
Country
France

12. IPD Sharing Statement

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Diagnostic Value of MRI for Allergic Broncho-Pulmonary Aspergilloses

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