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

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.

Study Overview

• Status: Completed
• Conditions: Sarcoidosis, Pulmonary
• Intervention / Treatment: Other: Patients with 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 Type: Interventional
• Enrollment (Actual): 196
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bobigny, France
    • CH de Bobigny, Hôpital Avicenne
  • Brest, France
    • CHU de Brest
  • Lorient, France
    • CH de Lorient
  • Nantes, France
    • CHU de Nantes
  • Rennes, France
    • Chu Rennes
  • Saint-Brieuc, France
    • CH de Saint-Brieuc
  • Vannes, France
    • CH de Vannes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with thoracic sarcoidosis; Patients routinely followed-up for thoracic sarcoidosis with a CT scan indicated in the follow-up	Other: Patients with thoracic sarcoidosis; Ultra-low dose CT scan and MRI with UTE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

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

Collaborators and Investigators

• Sponsor: Rennes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2017
• Primary Completion (Actual): October 15, 2021
• Study Completion (Actual): October 15, 2021

Study Registration Dates

• First Submitted: April 25, 2017
• First Submitted That Met QC Criteria: May 2, 2017
• First Posted (Actual): May 4, 2017

Study Record Updates

• Last Update Posted (Actual): May 17, 2023
• Last Update Submitted That Met QC Criteria: May 16, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: thoracic sarcoidosis; ultra-low dose computed tomography; Magnetic resonance imaging using Ultrashort echo time
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Lung Diseases; Lung Diseases, Interstitial; Sarcoidosis, Pulmonary; Sarcoidosis
• Other Study ID Numbers: 2016-A01781-50; 35RC16_9760 (Other Identifier: CHU Rennes)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No