Diagnostic Value of MRI for Allergic Broncho-Pulmonary Aspergilloses

NCT ID: NCT03265366

Last Updated: 2022-02-10

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-14

Study Completion Date

2020-01-24

Brief Summary

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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

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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.

Conditions

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Allergic Bronchopulmonary Aspergilloses

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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ABPA

15 patients with ABPA

Group Type EXPERIMENTAL

MRI

Intervention Type DEVICE

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

CT scan (standard reference)

Intervention Type DEVICE

It will be performed on a 16 (Sensation 16, Siemens®) or 64 channels (Definition 64, Siemens®), without contrast agent injection.

Severe asthma

12 patients with severe asthma

Group Type ACTIVE_COMPARATOR

MRI

Intervention Type DEVICE

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

CT scan (standard reference)

Intervention Type DEVICE

It will be performed on a 16 (Sensation 16, Siemens®) or 64 channels (Definition 64, Siemens®), without contrast agent injection.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julie MACEY, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

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CHU de Bordeaux

Pessac, , France

Site Status

Countries

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France

Other Identifiers

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CHUBX 2016/12

Identifier Type: -

Identifier Source: org_study_id

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