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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03265366
Other study ID # CHUBX 2016/12
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 14, 2017
Est. completion date January 24, 2020

Study information

Verified date February 2022
Source University Hospital, Bordeaux
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date January 24, 2020
Est. primary completion date January 24, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
France CHU de Bordeaux Pessac

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Concordance between chest CT scan and MRI for bronchial and pulmonary signs of ABPA (bronchiectases, infiltrates, impactions) Measured by a kappa test Day 0
See also
  Status Clinical Trial Phase
Completed NCT03133299 - A Study Evaluating Vitamin D in Allergic Bronchopulmonary Aspergillosis Complicating Asthma Phase 2/Phase 3