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Completed

NCT Number: NCT03140644

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CH de Bobigny, Hôpital Avicenne, Bobigny, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patients with thoracic sarcoidosis

Other

Ultra-low dose CT scan and MRI with UTE

Primary outcomes

  1. 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

Secondary outcomes

  1. Percentage of ground-glass opacity within the 2 lungs in standard CT and ULD CT

    Time frame: Day 0

  2. Percentage of consolidation within the 2 lungs in standard CT and ULD CT

    Time frame: Day 0

  3. Percentage of pulmonary nodules within the 2 lungs in standard CT and ULD CT

    Time frame: Day 0

  4. Percentage of fibrosis within the 2 lungs in standard CT and UTE MRI

    Time frame: Day 0

  5. Percentage of ground-glass opacity within the 2 lungs in standard CT and UTE MRI

    Time frame: Day 0

  6. Percentage of consolidation within the 2 lungs in standard CT and UTE MRI

    Time frame: Day 0

  7. Percentage of pulmonary nodules within the 2 lungs in standard CT and UTE MRI

    Time frame: Day 0

  8. Main pulmonary artery to ascending aorta diameter ratio measured with standard CT

    Time frame: Day 0

  9. Main pulmonary artery to ascending aorta diameter ratio measured with ULD CT

    Time frame: Day 0

  10. Main pulmonary artery to ascending aorta diameter ratio measured with UTE MRI

    Time frame: Day 0

  11. Drent score adapted from Oberstein with standard CT

    Time frame: Day 0

  12. Drent score adapted from Oberstein with ULD CT

    Time frame: Day 0

  13. Drent score adapted from Oberstein with UTE MRI

    Time frame: Day 0

  14. Percentage of fibrosis measured by 2 readers for standard CT

    Time frame: Day 0

  15. Percentage of fibrosis measured by 2 readers for ULD CT

    Time frame: Day 0

  16. Percentage of fibrosis measured by 2 readers for UTE MRI

    Time frame: Day 0

  17. Image quality of lung parenchyma assessed quantitatively using standard CT

    Time frame: Day 0

    signal-to-noise and contrast-to-noise ratios

  18. Image quality of lung parenchyma assessed quantitatively using ULD CT

    Time frame: Day 0

    signal-to-noise and contrast-to-noise ratios

  19. Image quality of lung parenchyma assessed quantitatively using UTE MRI

    Time frame: Day 0

    signal-to-noise and contrast-to-noise ratios

  20. Image quality of lung parenchyma assessed qualitatively using standard CT

    Time frame: Day 0

    4-level scale

  21. Image quality of lung parenchyma assessed qualitatively using ULD CT

    Time frame: Day 0

    4-level scale

  22. Image quality of lung parenchyma assessed qualitatively using UTE MRI

    Time frame: Day 0

    4-level scale

  23. Score of tolerance for CT examinations

    Time frame: Day 0

  24. Score of tolerance for MRI examinations

    Time frame: Day 0

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Acronym: SARCOLOWDOSE

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
May 4, 2017
Registry last updated
May 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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