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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03140644
Recruitment Status : Completed
First Posted : May 4, 2017
Last Update Posted : May 17, 2023
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sarcoidosis, Pulmonary Other: Patients with thoracic sarcoidosis Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 196 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: SARCOLOWDOSE : Ultra-low Dose CT Scan and MRI in Thoracic Sarcoidosis
Actual Study Start Date : May 16, 2017
Actual Primary Completion Date : October 15, 2021
Actual Study Completion Date : October 15, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03140644


Locations
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France
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
Sponsors and Collaborators
Rennes University Hospital
More Information
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Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT03140644    
Other Study ID Numbers: 2016-A01781-50
35RC16_9760 ( Other Identifier: CHU Rennes )
First Posted: May 4, 2017    Key Record Dates
Last Update Posted: May 17, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rennes University Hospital:
thoracic sarcoidosis
ultra-low dose computed tomography
Magnetic resonance imaging using Ultrashort echo time
Additional relevant MeSH terms:
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Sarcoidosis, Pulmonary
Sarcoidosis
Lymphoproliferative Disorders
Lymphatic Diseases
Hypersensitivity, Delayed
 Hypersensitivity
Immune System Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases