Sarcoidosis, PulmonarySARCOLOWDOSENCT03140644
SARCOLOWDOSE : Ultra-low Dose CT Scan and MRI in Thoracic Sarcoidosis
A study testing Patients with thoracic sarcoidosis in people with Sarcoidosis, Pulmonary, run by Rennes University Hospital at 7 sites in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcoidosis, Pulmonary
- What is being tested?
- Patients with thoracic sarcoidosis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 7 sitesFrance
- Study dates
- 16 May 2017to 15 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Pregnant woman
- Adult person unable to give consent
- Patient in exclusion period du to another protocol
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
CH de Bobigny, Hôpital Avicenne
Bobigny
CHU de Brest
Brest
CH de Lorient
Lorient
CHU de Nantes
Nantes
CHU Rennes
Rennes
CH de Saint-Brieuc
Saint-Brieuc
CH de Vannes
Vannes
About this study
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.
Read the 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.
- Conditions
- Sarcoidosis, Pulmonary
- Being tested
- Patients with thoracic sarcoidosis
- Keywords
- thoracic sarcoidosis, ultra-low dose computed tomography, Magnetic resonance imaging using Ultrashort echo time
- Medical subject headings
- Sarcoidosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients with thoracic sarcoidosisOther
Ultra-low dose CT scan and MRI with UTE
| Study group | Role | What they receive |
|---|---|---|
| Patients with thoracic sarcoidosis | Experimental | Patients routinely followed-up for thoracic sarcoidosis with a CT scan indicated in the follow-up Receives: Other: Patients with thoracic sarcoidosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 0
Secondary outcomes (24)
Percentage of ground-glass opacity within the 2 lungs in standard CT and ULD CT
Measured: Day 0
Percentage of consolidation within the 2 lungs in standard CT and ULD CT
Measured: Day 0
Percentage of pulmonary nodules within the 2 lungs in standard CT and ULD CT
Measured: Day 0
Percentage of fibrosis within the 2 lungs in standard CT and UTE MRI
Measured: Day 0
Percentage of ground-glass opacity within the 2 lungs in standard CT and UTE MRI
Measured: Day 0
Percentage of consolidation within the 2 lungs in standard CT and UTE MRI
Measured: Day 0
Percentage of pulmonary nodules within the 2 lungs in standard CT and UTE MRI
Measured: Day 0
Main pulmonary artery to ascending aorta diameter ratio measured with standard CT
Measured: Day 0
Main pulmonary artery to ascending aorta diameter ratio measured with ULD CT
Measured: Day 0
Main pulmonary artery to ascending aorta diameter ratio measured with UTE MRI
Measured: Day 0
Drent score adapted from Oberstein with standard CT
Measured: Day 0
Drent score adapted from Oberstein with ULD CT
Measured: Day 0
Drent score adapted from Oberstein with UTE MRI
Measured: Day 0
Percentage of fibrosis measured by 2 readers for standard CT
Measured: Day 0
Percentage of fibrosis measured by 2 readers for ULD CT
Measured: Day 0
Percentage of fibrosis measured by 2 readers for UTE MRI
Measured: Day 0
Image quality of lung parenchyma assessed quantitatively using standard CT
signal-to-noise and contrast-to-noise ratios
Measured: Day 0
Image quality of lung parenchyma assessed quantitatively using ULD CT
signal-to-noise and contrast-to-noise ratios
Measured: Day 0
Image quality of lung parenchyma assessed quantitatively using UTE MRI
signal-to-noise and contrast-to-noise ratios
Measured: Day 0
Image quality of lung parenchyma assessed qualitatively using standard CT
4-level scale
Measured: Day 0
Image quality of lung parenchyma assessed qualitatively using ULD CT
4-level scale
Measured: Day 0
Image quality of lung parenchyma assessed qualitatively using UTE MRI
4-level scale
Measured: Day 0
Score of tolerance for CT examinations
Measured: Day 0
Score of tolerance for MRI examinations
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start16 May 2017
- Primary completion15 Oct 2021
- Study completion15 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcoidosis, PulmonaryStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03140644
- Sponsor's protocol ID
- 2016-A01781-50
- Other IDs
- 35RC16_9760
- Acronym
- SARCOLOWDOSE
- Status last verified
- May 2023
- First submitted
- 25 Apr 2017
- Last updated
- 17 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SARCOLOWDOSE : Ultra-low Dose CT Scan and MRI in Thoracic Sarcoidosis
- ClinicalTrials.gov ID
- NCT03140644
- Acronym / sponsor ID
- SARCOLOWDOSE / 2016-A01781-50
- Conditions
- Sarcoidosis, Pulmonary
- Keywords
- thoracic sarcoidosis, ultra-low dose computed tomography, Magnetic resonance imaging using Ultrashort echo time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 16 May 2017 (actual)
- Primary completion
- 15 Oct 2021 (actual)
- Study completion
- 15 Oct 2021 (actual)
- First posted
- 4 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with thoracic sarcoidosis | Experimental | Other: Patients with thoracic sarcoidosisPatients routinely followed-up for thoracic sarcoidosis with a CT scan indicated in the follow-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- Pregnant woman
- Adult person unable to give consent
- Patient in exclusion period du to another protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients with thoracic sarcoidosisUltra-low dose CT scan and MRI with UTE | Other | Patients with thoracic sarcoidosis |
Primary outcome
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
24 secondary outcomes
Percentage of ground-glass opacity within the 2 lungs in standard CT and ULD CT
Time frame: Day 0
Percentage of consolidation within the 2 lungs in standard CT and ULD CT
Time frame: Day 0
Percentage of pulmonary nodules within the 2 lungs in standard CT and ULD CT
Time frame: Day 0
Percentage of fibrosis within the 2 lungs in standard CT and UTE MRI
Time frame: Day 0
Percentage of ground-glass opacity within the 2 lungs in standard CT and UTE MRI
Time frame: Day 0
Percentage of consolidation within the 2 lungs in standard CT and UTE MRI
Time frame: Day 0
Percentage of pulmonary nodules within the 2 lungs in standard CT and UTE MRI
Time frame: Day 0
Main pulmonary artery to ascending aorta diameter ratio measured with standard CT
Time frame: Day 0
Main pulmonary artery to ascending aorta diameter ratio measured with ULD CT
Time frame: Day 0
Main pulmonary artery to ascending aorta diameter ratio measured with UTE MRI
Time frame: Day 0
Drent score adapted from Oberstein with standard CT
Time frame: Day 0
Drent score adapted from Oberstein with ULD CT
Time frame: Day 0
Drent score adapted from Oberstein with UTE MRI
Time frame: Day 0
Percentage of fibrosis measured by 2 readers for standard CT
Time frame: Day 0
Percentage of fibrosis measured by 2 readers for ULD CT
Time frame: Day 0
Percentage of fibrosis measured by 2 readers for UTE MRI
Time frame: Day 0
Image quality of lung parenchyma assessed quantitatively using standard CT
Time frame: Day 0
Image quality of lung parenchyma assessed quantitatively using ULD CT
Time frame: Day 0
Image quality of lung parenchyma assessed quantitatively using UTE MRI
Time frame: Day 0
Image quality of lung parenchyma assessed qualitatively using standard CT
Time frame: Day 0
Image quality of lung parenchyma assessed qualitatively using ULD CT
Time frame: Day 0
Image quality of lung parenchyma assessed qualitatively using UTE MRI
Time frame: Day 0
Score of tolerance for CT examinations
Time frame: Day 0
Score of tolerance for MRI examinations
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patients with thoracic sarcoidosis in people with Sarcoidosis, Pulmonary, run by Rennes University Hospital at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2023.