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Trial record 6 of 23 for:    Recruiting, Not yet recruiting, Available Studies | "Aspergillosis"

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

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ClinicalTrials.gov Identifier: NCT03265366
Recruitment Status : Not yet recruiting
First Posted : August 29, 2017
Last Update Posted : August 30, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

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
Allergic Bronchopulmonary Aspergilloses Device: MRI Device: CT scan (standard reference) Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 27 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
Estimated Study Start Date : September 2017
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aspergillosis

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.




Primary Outcome Measures :
  1. Concordance between chest CT scan and MRI for bronchial and pulmonary signs of ABPA (bronchiectases, infiltrates, impactions) [ Time Frame: Day 0 ]
    Measured by a kappa test



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03265366


Contacts
Contact: Julie MACEY, MD (0)5 57 62 32 90 ext +33 julie.macey@chu-bordeaux.fr
Contact: Rkia ACHKIR (0)5 56 79 56 79 ext +33 rkia.achkir@chu-bordeaux.fr

Locations
France
CHU de Bordeaux Not yet recruiting
Pessac, France, 33604
Contact: Julie MACEY, MD    (0)5 57 62 32 90 ext +33    julie.macey@chu-bordeaux.fr   
Contact: Rkia ACHKIR    (0)5 56 79 56 79 ext +33    rkia.achkir@chu-bordeaux.fr   
Principal Investigator: Julie MACEY, MD         
Sub-Investigator: François LAURENT, MD PhD         
Sub-Investigator: Gaël DOURNES, MD         
Sub-Investigator: Chantal RAHERISON-SEMJEN, MD PhD         
Sub-Investigator: Elodie BLANCHARD, MD         
Sub-Investigator: Claire DROMER, MD         
Sub-Investigator: Xavier DEMANT, MD         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Julie MACEY, MD University Hospital, Bordeaux

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT03265366     History of Changes
Other Study ID Numbers: CHUBX 2016/12
First Posted: August 29, 2017    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: August 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Bordeaux:
Ultrashort echo time magnetic resonance imaging

Additional relevant MeSH terms:
Aspergillosis
Pulmonary Aspergillosis
Aspergillosis, Allergic Bronchopulmonary
Mycoses
Hyalohyphomycosis
Dermatomycoses
Lung Diseases, Fungal
Skin Diseases, Infectious
Skin Diseases
Lung Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Respiratory Tract Infections
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases