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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03140644
Acronym
SARCOLOWDOSE
Enrollment
196
Registered
2017-05-04
Start date
2017-05-16
Completion date
2021-10-15
Last updated
2023-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcoidosis, Pulmonary

Keywords

thoracic sarcoidosis, ultra-low dose computed tomography, Magnetic resonance imaging using Ultrashort echo time

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 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.

Interventions

OTHERPatients with thoracic sarcoidosis

Ultra-low dose CT scan and MRI with UTE

Sponsors

Rennes University Hospital
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Percentage of fibrosis within the 2 lungs (reticulations with or without honeycombing) in standard CT and ULD CT to study diagnostic agreement between these techniquesDay 0

Secondary

MeasureTime frameDescription
Percentage of consolidation within the 2 lungs in standard CT and ULD CTDay 0
Percentage of pulmonary nodules within the 2 lungs in standard CT and ULD CTDay 0
Percentage of fibrosis within the 2 lungs in standard CT and UTE MRIDay 0
Percentage of ground-glass opacity within the 2 lungs in standard CT and UTE MRIDay 0
Percentage of consolidation within the 2 lungs in standard CT and UTE MRIDay 0
Percentage of pulmonary nodules within the 2 lungs in standard CT and UTE MRIDay 0
Main pulmonary artery to ascending aorta diameter ratio measured with standard CTDay 0
Main pulmonary artery to ascending aorta diameter ratio measured with ULD CTDay 0
Main pulmonary artery to ascending aorta diameter ratio measured with UTE MRIDay 0
Drent score adapted from Oberstein with standard CTDay 0
Drent score adapted from Oberstein with ULD CTDay 0
Percentage of ground-glass opacity within the 2 lungs in standard CT and ULD CTDay 0
Percentage of fibrosis measured by 2 readers for standard CTDay 0
Percentage of fibrosis measured by 2 readers for ULD CTDay 0
Percentage of fibrosis measured by 2 readers for UTE MRIDay 0
Image quality of lung parenchyma assessed quantitatively using standard CTDay 0signal-to-noise and contrast-to-noise ratios
Image quality of lung parenchyma assessed quantitatively using ULD CTDay 0signal-to-noise and contrast-to-noise ratios
Image quality of lung parenchyma assessed quantitatively using UTE MRIDay 0signal-to-noise and contrast-to-noise ratios
Image quality of lung parenchyma assessed qualitatively using standard CTDay 04-level scale
Image quality of lung parenchyma assessed qualitatively using ULD CTDay 04-level scale
Image quality of lung parenchyma assessed qualitatively using UTE MRIDay 04-level scale
Score of tolerance for CT examinationsDay 0
Score of tolerance for MRI examinationsDay 0
Drent score adapted from Oberstein with UTE MRIDay 0

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026