Clinical trial NCT03140644: SARCOLOWDOSE : Ultra-low Dose CT Scan and MRI in Thoracic Sarcoidosis
Official title: SARCOLOWDOSE : Ultra-low Dose CT Scan and MRI in Thoracic Sarcoidosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sarcoidosis, Pulmonary
Keywords: thoracic sarcoidosis
ultra-low dose computed tomography
Magnetic resonance imaging using Ultrashort echo time
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2017-05-04
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this study is to evaluate the diagnostic agreement between, on the one hand, ultra-low dose CT and MRI with UTE pulse sequences, and on the other hand, standard CT scan, to quantify lung parenchyma patterns in thoracic sarcoidosis.

Detailed description: Sarcoidosis is a chronic disease involving lung and mediastinum in more than 90% of cases. Five to 25% of thoracic sarcoidosis are complicated by a severe fibrotic lung disease. Computed tomography (CT) is critical for the diagnosis of thoracic sarcoidosis as well as for therapeutic management. Repeated CT examinations, sometimes all life long, raise the issue of the cumulative radiation dose and subsequent risk of cancer, thus pushing the need for imaging techniques using low or no radiation dose. Based upon tube voltage and current reduction as well as iterative recontsruction, ultra-low dose CT (ULD CT) allows to lower the dose up to that of a traditional chest X-ray. Magnetic resonance imaging (MRI) using Ultrashort echo time (UTE) enables lung parenchyma imaging with high signal-to-noise and spatial resolution.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 years or more
* Diagnosed with thoracic sarcoidosis according to ATS/ERS/WASOG 1999 criteria, with stages 2, 3 or 4, or lung function significantly impaired
* For whom a chest CT examination without contrast medium is indicated in the normal follow-up of the disease
* covered by social security
* having received information about the study and having given written informed consent

Exclusion Criteria:

* Pregnant woman
* Adult person unable to give consent
* Patient in exclusion period du to another protocol

Primary outcomes:
measure: Percentage of fibrosis within the 2 lungs (reticulations with or without honeycombing) in standard CT and ULD CT to study diagnostic agreement between these techniques
timeFrame: Day 0
Secondary outcomes:
measure: Percentage of ground-glass opacity within the 2 lungs in standard CT and ULD CT
timeFrame: Day 0
measure: Percentage of consolidation within the 2 lungs in standard CT and ULD CT
timeFrame: Day 0
measure: Percentage of pulmonary nodules within the 2 lungs in standard CT and ULD CT
timeFrame: Day 0
measure: Percentage of fibrosis within the 2 lungs in standard CT and UTE MRI
timeFrame: Day 0
measure: Percentage of ground-glass opacity within the 2 lungs in standard CT and UTE MRI
timeFrame: Day 0
measure: Percentage of consolidation within the 2 lungs in standard CT and UTE MRI
timeFrame: Day 0
measure: Percentage of pulmonary nodules within the 2 lungs in standard CT and UTE MRI
timeFrame: Day 0
measure: Main pulmonary artery to ascending aorta diameter ratio measured with standard CT
timeFrame: Day 0
measure: Main pulmonary artery to ascending aorta diameter ratio measured with ULD CT
timeFrame: Day 0
measure: Main pulmonary artery to ascending aorta diameter ratio measured with UTE MRI
timeFrame: Day 0
measure: Drent score adapted from Oberstein with standard CT
timeFrame: Day 0
measure: Drent score adapted from Oberstein with ULD CT
timeFrame: Day 0
measure: Drent score adapted from Oberstein with UTE MRI
timeFrame: Day 0
measure: Percentage of fibrosis measured by 2 readers for standard CT
timeFrame: Day 0
measure: Percentage of fibrosis measured by 2 readers for ULD CT
timeFrame: Day 0
measure: Percentage of fibrosis measured by 2 readers for UTE MRI
timeFrame: Day 0
measure: Image quality of lung parenchyma assessed quantitatively using standard CT
timeFrame: Day 0
measure: Image quality of lung parenchyma assessed quantitatively using ULD CT
timeFrame: Day 0
measure: Image quality of lung parenchyma assessed quantitatively using UTE MRI
timeFrame: Day 0
measure: Image quality of lung parenchyma assessed qualitatively using standard CT
timeFrame: Day 0
measure: Image quality of lung parenchyma assessed qualitatively using ULD CT
timeFrame: Day 0
measure: Image quality of lung parenchyma assessed qualitatively using UTE MRI
timeFrame: Day 0
measure: Score of tolerance for CT examinations
timeFrame: Day 0
measure: Score of tolerance for MRI examinations
timeFrame: Day 0
Other outcomes:
Locations:
city: Bobigny
country: France
facility: CH de Bobigny, Hôpital Avicenne
city: Brest
country: France
facility: CHU de Brest
city: Lorient
country: France
facility: CH de Lorient
city: Nantes
country: France
facility: CHU de Nantes
city: Rennes
country: France
facility: CHU Rennes
city: Saint-Brieuc
country: France
facility: CH de Saint-Brieuc
city: Vannes
country: France
facility: CH de Vannes
Study officials:
References: