Sarcoidosis, Pulmonary Clinical Trial
— SARCOLOWDOSEOfficial title:
SARCOLOWDOSE : Ultra-low Dose CT Scan and MRI in Thoracic Sarcoidosis
Verified date | May 2023 |
Source | Rennes University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 196 |
Est. completion date | October 15, 2021 |
Est. primary completion date | October 15, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
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 |
Lead Sponsor | Collaborator |
---|---|
Rennes University Hospital |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Percentage of ground-glass opacity within the 2 lungs in standard CT and ULD CT | Day 0 | ||
Secondary | Percentage of consolidation within the 2 lungs in standard CT and ULD CT | Day 0 | ||
Secondary | Percentage of pulmonary nodules within the 2 lungs in standard CT and ULD CT | Day 0 | ||
Secondary | Percentage of fibrosis within the 2 lungs in standard CT and UTE MRI | Day 0 | ||
Secondary | Percentage of ground-glass opacity within the 2 lungs in standard CT and UTE MRI | Day 0 | ||
Secondary | Percentage of consolidation within the 2 lungs in standard CT and UTE MRI | Day 0 | ||
Secondary | Percentage of pulmonary nodules within the 2 lungs in standard CT and UTE MRI | Day 0 | ||
Secondary | Main pulmonary artery to ascending aorta diameter ratio measured with standard CT | Day 0 | ||
Secondary | Main pulmonary artery to ascending aorta diameter ratio measured with ULD CT | Day 0 | ||
Secondary | Main pulmonary artery to ascending aorta diameter ratio measured with UTE MRI | Day 0 | ||
Secondary | Drent score adapted from Oberstein with standard CT | Day 0 | ||
Secondary | Drent score adapted from Oberstein with ULD CT | Day 0 | ||
Secondary | Drent score adapted from Oberstein with UTE MRI | Day 0 | ||
Secondary | Percentage of fibrosis measured by 2 readers for standard CT | Day 0 | ||
Secondary | Percentage of fibrosis measured by 2 readers for ULD CT | Day 0 | ||
Secondary | Percentage of fibrosis measured by 2 readers for UTE MRI | Day 0 | ||
Secondary | Image quality of lung parenchyma assessed quantitatively using standard CT | signal-to-noise and contrast-to-noise ratios | Day 0 | |
Secondary | Image quality of lung parenchyma assessed quantitatively using ULD CT | signal-to-noise and contrast-to-noise ratios | Day 0 | |
Secondary | Image quality of lung parenchyma assessed quantitatively using UTE MRI | signal-to-noise and contrast-to-noise ratios | Day 0 | |
Secondary | Image quality of lung parenchyma assessed qualitatively using standard CT | 4-level scale | Day 0 | |
Secondary | Image quality of lung parenchyma assessed qualitatively using ULD CT | 4-level scale | Day 0 | |
Secondary | Image quality of lung parenchyma assessed qualitatively using UTE MRI | 4-level scale | Day 0 | |
Secondary | Score of tolerance for CT examinations | Day 0 | ||
Secondary | Score of tolerance for MRI examinations | Day 0 |
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