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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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

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 Summary: 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.
Sponsor: Rennes University Hospital

Current Primary Outcome: 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 [ Time Frame: Day 0 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Rennes University Hospital

Dates:
Date Received: April 25, 2017
Date Started: May 2017
Date Completion: November 2019
Last Updated: May 2, 2017
Last Verified: April 2017