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

Primary Purpose

Sarcoidosis, Pulmonary

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Patients with thoracic sarcoidosis
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sarcoidosis, Pulmonary focused on measuring thoracic sarcoidosis, ultra-low dose computed tomography, Magnetic resonance imaging using Ultrashort echo time

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CH de Bobigny, Hôpital Avicenne
  • CHU de Brest
  • CH de Lorient
  • CHU de Nantes
  • CHU Rennes
  • CH de Saint-Brieuc
  • CH de Vannes

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with thoracic sarcoidosis

Arm Description

Patients routinely followed-up for thoracic sarcoidosis with a CT scan indicated in the follow-up

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
April 25, 2017
Last Updated
May 16, 2023
Sponsor
Rennes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03140644
Brief Title
SARCOLOWDOSE : Ultra-low Dose CT Scan and MRI in Thoracic Sarcoidosis
Acronym
SARCOLOWDOSE
Official Title
SARCOLOWDOSE : Ultra-low Dose CT Scan and MRI in Thoracic Sarcoidosis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
May 16, 2017 (Actual)
Primary Completion Date
October 15, 2021 (Actual)
Study Completion Date
October 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoidosis, Pulmonary
Keywords
thoracic sarcoidosis, ultra-low dose computed tomography, Magnetic resonance imaging using Ultrashort echo time

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
196 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with thoracic sarcoidosis
Arm Type
Experimental
Arm Description
Patients routinely followed-up for thoracic sarcoidosis with a CT scan indicated in the follow-up
Intervention Type
Other
Intervention Name(s)
Patients with thoracic sarcoidosis
Intervention Description
Ultra-low dose CT scan and MRI with UTE
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Percentage of ground-glass opacity within the 2 lungs in standard CT and ULD CT
Time Frame
Day 0
Title
Percentage of consolidation within the 2 lungs in standard CT and ULD CT
Time Frame
Day 0
Title
Percentage of pulmonary nodules within the 2 lungs in standard CT and ULD CT
Time Frame
Day 0
Title
Percentage of fibrosis within the 2 lungs in standard CT and UTE MRI
Time Frame
Day 0
Title
Percentage of ground-glass opacity within the 2 lungs in standard CT and UTE MRI
Time Frame
Day 0
Title
Percentage of consolidation within the 2 lungs in standard CT and UTE MRI
Time Frame
Day 0
Title
Percentage of pulmonary nodules within the 2 lungs in standard CT and UTE MRI
Time Frame
Day 0
Title
Main pulmonary artery to ascending aorta diameter ratio measured with standard CT
Time Frame
Day 0
Title
Main pulmonary artery to ascending aorta diameter ratio measured with ULD CT
Time Frame
Day 0
Title
Main pulmonary artery to ascending aorta diameter ratio measured with UTE MRI
Time Frame
Day 0
Title
Drent score adapted from Oberstein with standard CT
Time Frame
Day 0
Title
Drent score adapted from Oberstein with ULD CT
Time Frame
Day 0
Title
Drent score adapted from Oberstein with UTE MRI
Time Frame
Day 0
Title
Percentage of fibrosis measured by 2 readers for standard CT
Time Frame
Day 0
Title
Percentage of fibrosis measured by 2 readers for ULD CT
Time Frame
Day 0
Title
Percentage of fibrosis measured by 2 readers for UTE MRI
Time Frame
Day 0
Title
Image quality of lung parenchyma assessed quantitatively using standard CT
Description
signal-to-noise and contrast-to-noise ratios
Time Frame
Day 0
Title
Image quality of lung parenchyma assessed quantitatively using ULD CT
Description
signal-to-noise and contrast-to-noise ratios
Time Frame
Day 0
Title
Image quality of lung parenchyma assessed quantitatively using UTE MRI
Description
signal-to-noise and contrast-to-noise ratios
Time Frame
Day 0
Title
Image quality of lung parenchyma assessed qualitatively using standard CT
Description
4-level scale
Time Frame
Day 0
Title
Image quality of lung parenchyma assessed qualitatively using ULD CT
Description
4-level scale
Time Frame
Day 0
Title
Image quality of lung parenchyma assessed qualitatively using UTE MRI
Description
4-level scale
Time Frame
Day 0
Title
Score of tolerance for CT examinations
Time Frame
Day 0
Title
Score of tolerance for MRI examinations
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
CH de Bobigny, Hôpital Avicenne
City
Bobigny
Country
France
Facility Name
CHU de Brest
City
Brest
Country
France
Facility Name
CH de Lorient
City
Lorient
Country
France
Facility Name
CHU de Nantes
City
Nantes
Country
France
Facility Name
CHU Rennes
City
Rennes
Country
France
Facility Name
CH de Saint-Brieuc
City
Saint-Brieuc
Country
France
Facility Name
CH de Vannes
City
Vannes
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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