NCT02100800

Brief Summary

Emphysema is a major pathological feature of Chronic Obstructive Pulmonary Disease (COPD). Non-invasive assessment of emphysema is a crucial issue for the phenotype and follow-up of COPD patients. Currently, CT is the method of reference to evaluate and quantify emphysema but it remains a radiation-based technique. Magnetic Resonance Imagery (MRI) with ultrashort echo time (UTE) pulse sequences is a promising non-ionizing alternative for lung imaging. Our objective is to evaluate emphysema in COPD patients using CT and MR-UTE, and to test the agreement between both techniques.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 1, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

May 23, 2014

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2016

Completed
Last Updated

February 9, 2022

Status Verified

February 1, 2022

Enrollment Period

2.1 years

First QC Date

March 18, 2014

Last Update Submit

February 8, 2022

Conditions

Emphysema

Keywords

COPDEmphysemaMRIUTEQuantificationCT

Outcome Measures

Primary Outcomes (1)

  • Agreement between MRI and CT for evaluating the regional distribution of emphysema

    MRI and CT evaluation of regional distribution of emphysema will be assessed by 2 blind radiologists. Agreement between both evaluation will be assessed during statistical analyses after study completion

    During MRI and CT, Day one

Secondary Outcomes (7)

  • Agreement between MRI and CT for evaluating the presence of emphysema

    During MRI and CT, Day one

  • Correlation between emphysema scoring extracted from CT and MR images

    During MRI and CT, Day one

  • MR emphysema reproductibility scoring over the time

    During MRI, Day one

  • Comparison of MR emphysema scoring and lung signal values between COPD and controls

    During MRI, Day one

  • Comparison of MR emphysema scoring between different GOLD stages

    During MRI, Day one

  • +2 more secondary outcomes

Study Arms (2)

COPD Group

EXPERIMENTAL

30 patients with diagnosis of COPD

Other: MR and CT measurements of emphysema quantification

Control Group

SHAM COMPARATOR

10 volunteers with extrapulmonary neoplasia

Other: MR and CT measurements of emphysema quantification

Interventions

MR and CT measurements of emphysema quantificationOTHER
COPD GroupControl Group

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female aged more than 40 years.
  • With a written informed consent and health insurance.

You may not qualify if:

  • Subjects without any social security or health insurance.
  • History of asthma, lung fibrosis, pulmonary hypertension or cystic fibrosis.
  • Pregnancy.
  • Any respiratory treatment for control subjects.
  • MRI contraindications: Magnetically activated implanted devices (cardiac pacemakers, insulin pumps, neurostimulators, cochlear implants), metal inside the eye or the brain (aneurysm clip, ocular foreign body), cardiac valvular prosthesis (Starr-Edwards pre-6000), subject with claustrophobia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Bordeaux

Pessac, 33604, France

Location

Related Publications (1)

  • Benlala I, Berger P, Girodet PO, Dromer C, Macey J, Laurent F, Dournes G. Automated Volumetric Quantification of Emphysema Severity by Using Ultrashort Echo Time MRI: Validation in Participants with Chronic Obstructive Pulmonary Disease. Radiology. 2019 Jul;292(1):216-225. doi: 10.1148/radiol.2019190052. Epub 2019 Jun 4.

    PMID: 31161972DERIVED

MeSH Terms

Conditions

EmphysemaPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsLung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease Attributes

Study Officials

  • Gaël DOURNES, MD

    University Hospital Bordeaux (France)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2014

First Posted

April 1, 2014

Study Start

May 23, 2014

Primary Completion

July 13, 2016

Study Completion

July 13, 2016

Last Updated

February 9, 2022

Record last verified: 2022-02

Locations

FR(1)