SARCOLOWDOSE : Ultra-low Dose CT Scan and MRI in Thoracic Sarcoidosis

Not Applicable

Completed

• Conditions: Sarcoidosis, Pulmonary
• Interventions: Other: Patients with thoracic sarcoidosis

• Registration Number: NCT03140644
• Lead Sponsor: Rennes University Hospital

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.

Study Timeline

• Study First Submitted: 2017-04-25
• Study First Submitted QC: 2017-05-02
• Study First Posted: 2017-05-04
• Study Start: 2017-05-16
• Primary Completion: 2021-10-15
• Study Completion: 2021-10-15
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-16
• Last Update Posted: 2023-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 196

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with thoracic sarcoidosis	Patients with thoracic sarcoidosis	Patients routinely followed-up for thoracic sarcoidosis with a CT scan indicated in the follow-up

Primary Outcome Measures

Name	Time	Method
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	Day 0

Secondary Outcome Measures

Name	Time	Method
Image quality of lung parenchyma assessed qualitatively using UTE MRI	Day 0	4-level scale
Score of tolerance for CT examinations	Day 0
Main pulmonary artery to ascending aorta diameter ratio measured with UTE MRI	Day 0
Image quality of lung parenchyma assessed qualitatively using ULD CT	Day 0	4-level scale
Percentage of pulmonary nodules within the 2 lungs in standard CT and ULD CT	Day 0
Percentage of ground-glass opacity within the 2 lungs in standard CT and ULD CT	Day 0
Main pulmonary artery to ascending aorta diameter ratio measured with ULD CT	Day 0
Percentage of ground-glass opacity within the 2 lungs in standard CT and UTE MRI	Day 0
Drent score adapted from Oberstein with UTE MRI	Day 0
Percentage of fibrosis measured by 2 readers for ULD CT	Day 0
Percentage of consolidation within the 2 lungs in standard CT and ULD CT	Day 0
Image quality of lung parenchyma assessed quantitatively using ULD CT	Day 0	signal-to-noise and contrast-to-noise ratios
Percentage of fibrosis measured by 2 readers for UTE MRI	Day 0
Percentage of pulmonary nodules within the 2 lungs in standard CT and UTE MRI	Day 0
Score of tolerance for MRI examinations	Day 0
Percentage of fibrosis within the 2 lungs in standard CT and UTE MRI	Day 0
Percentage of consolidation within the 2 lungs in standard CT and UTE MRI	Day 0
Main pulmonary artery to ascending aorta diameter ratio measured with standard CT	Day 0
Drent score adapted from Oberstein with standard CT	Day 0
Drent score adapted from Oberstein with ULD CT	Day 0
Image quality of lung parenchyma assessed quantitatively using UTE MRI	Day 0	signal-to-noise and contrast-to-noise ratios
Image quality of lung parenchyma assessed qualitatively using standard CT	Day 0	4-level scale
Percentage of fibrosis measured by 2 readers for standard CT	Day 0
Image quality of lung parenchyma assessed quantitatively using standard CT	Day 0	signal-to-noise and contrast-to-noise ratios

Trial Locations

Locations (7)

CH de Bobigny, Hôpital Avicenne; 🇫🇷 Bobigny, France

CHU de Brest; 🇫🇷 Brest, France

CH de Lorient; 🇫🇷 Lorient, France

CHU de Nantes; 🇫🇷 Nantes, France

CHU Rennes; 🇫🇷 Rennes, France

CH de Saint-Brieuc; 🇫🇷 Saint-Brieuc, France

CH de Vannes; 🇫🇷 Vannes, France