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

Sarcoidosis, Pulmonary Clinical Trial

— SARCOLOWDOSE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03140644
• Other study ID #: 2016-A01781-50
• Secondary ID: 35RC16_9760
• Status: Completed
• Phase: N/A
• Start date: May 16, 2017
• Est. completion date: October 15, 2021

Study information

• Verified date: May 2023
• Source: Rennes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Sarcoidosis
• Sarcoidosis, Pulmonary

Intervention

Other:
• Patients with thoracic sarcoidosis
Ultra-low dose CT scan and MRI with UTE

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

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