Diagnostic Value of MRI for Allergic Broncho-Pulmonary Aspergilloses

NCT03265366 | Completed

• 1 other identifier: CHUBX 2016/12
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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).

Conditions

Allergic Bronchopulmonary Aspergilloses

Keywords

Ultrashort echo time magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

• Concordance between chest CT scan and MRI for bronchial and pulmonary signs of ABPA (bronchiectases, infiltrates, impactions)

  Measured by a kappa test

  Day 0

Study Arms (2)

ABPA

EXPERIMENTAL

15 patients with ABPA

Device: MRI; Device: CT scan (standard reference)

Severe asthma

ACTIVE COMPARATOR

12 patients with severe asthma

Device: MRI; Device: CT scan (standard reference)

Interventions

MRI 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.

ABPA; Severe asthma

CT scan (standard reference) DEVICE

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

ABPA; Severe asthma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• cystic fibrosis
• other type of aspergilloses
• contraindication for MRI
• woman without effective contraception

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

CHU de Bordeaux

Pessac, 33604, France

Location

MeSH Terms

Conditions

Aspergillosis, Allergic Bronchopulmonary

Interventions

Tomography, X-Ray Computed; Reference Standards

Condition Hierarchy (Ancestors)

Pulmonary Aspergillosis; Aspergillosis; Mycoses; Bacterial Infections and Mycoses; Infections; Lung Diseases, Fungal; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography; Weights and Measures; Investigative Techniques

Study Officials

• Julie MACEY, MD

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2017
• First Posted: August 29, 2017
• Study Start: September 14, 2017
• Primary Completion: January 24, 2020
• Study Completion: January 24, 2020
• Last Updated: February 10, 2022

Record last verified: 2022-02

Locations

FR (1)