Covid19COVID-19 ULDNCT04794361
Management of Patients Suspected of COVID 19 With Ultra Low Dose Thoracic Scanner
An observational study of Covid19, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
The year 2020 was marked by the emergence of a new respiratory disease: COVID19 related to an infection with the coronavirus SARS-CoV-2 (name given by the WHO on February 11, 2020). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 5 Mar 2020to 5 May 2020
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Patients from the Nîmes University Hospital who had a chest CT prescription for suspected COVID-19 since March 5, 2020 (start of the COVID-19 protocol) and until April 5
Who may be able to join
- Patients having had the LD and ULD acquisitions
Who cannot join
- scanner not passed through the COVID circuit, no ULD acquisition performed
Trial locations and contacts
1 site in 1 country.
About this study
The year 2020 was marked by the emergence of a new respiratory disease: COVID19 related to an infection with the coronavirus SARS-CoV-2 (name given by the WHO on February 11, 2020). Initially appearing in China, in the province of Hubei, this epidemic has rapidly spread to be declared a global pandemic on March 12, 2020 by the WHO.Given the current context of the COVID-19 epidemic, strict hygiene measures have been taken in scanning rooms with systematic bio-cleaning. Strategies have been modified as a matter of urgency, with changes in the practices of electro radiology manipulators who work in "isolation" to avoid contamination. The number of scanners has increased exponentially following the curve of the epidemic, making it more and more difficult to systematically check the images before the patient leaves the room. To ensure sufficient image quality for interpretation of all scans, a complementary acquisition in ULD, with very low exposure, was systematically added to the acquisition protocol. The standard acquisition in LD, associated with this acquisition in ULD remain well below the diagnostic reference thresholds dictated by the nuclear safety authority (NRD: 350 mGy.cm. In Nîmes: LD: 100 to 150 mGy.cm and ULD: < 15 mGy.cm). These two acquisitions allow us to avoid breathing and movement artifacts, etc., without having to have the patients return for a new scan in case of a bad acquisition. This avoids an overexposure of the staff to the risk of infection by the SARS-CoV-2 virus.
The main objective of this retrospective study is to evaluate the diagnostic performance of ULD vs. LD for the accurate diagnosis of COVID-19 pneumopathy which presents a particular ground glass pattern
Our study will demonstrate that the ULD scanner can be used in the search for COVID-19 pneumopathy and thus limit the exposure of patients to X-rays, especially since thoracic scans are often repeated.
Read the detailed description
Main objective To evaluate the diagnostic performance of ULD vs. LD scanning for the diagnosis of COVID-19 lung disease.
Primary endpoint LD and ULD acquisitions will be anonymized and randomized in a read list. Double reading of scans in a randomized and blinded manner of the results of LD and ULD acquisitions of chest scans performed for suspected COVID-19 by 2 radiologists (one junior and one senior). Scans will be classified as non-COVID and COVID. The reference will be the LD scan. In case of discrepancy, a third senior radiologist will be asked and the decision will be made by consensus.
Secondary objectives
- Objective evaluation of image quality (signal, noise, contrast to noise ratio)
- Subjective evaluation of image quality and confidence in interpretation.
- Specific study of ground glass signal in ULD
Secondary evaluation criteria
- Measurement of signal and noise in the image using ROIs positioned in the lung, trachea, fat, which measure the average signal intensity and its standard deviation. These measurements will be performed on LD and ULD acquisitions at the same locations.
- Likert scale to subjectively assess image quality and confidence in the diagnosis.
- Specific measurement of signal and noise in the ground glass using ROI positioned within the ground glass that measures the average signal intensity and its standard deviation. This measurement will be performed on LD and ULD acquisitions at the same location.
Population concerned Patients of the Nîmes University Hospital who have had a prescription for a thoracic CT scan for suspected COVID-19 since March 5, 2020 (beginning of the COVID-19 protocol) and until April 5. Patients having had the LD and ULD acquisitions.
- Conditions
- Covid19
- Medical subject headings
- COVID-19
What is being measured
The primary outcome is the main question the study is designed to answer.
reading of LD and ULD acquisitions
Diagnostic performance of ULD vs LD scanner for the diagnosis of COVID-19 pneumopathy
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2021
- Study start5 Mar 2020
- Primary completion5 May 2020
- Study completion5 May 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04794361
- Sponsor's protocol ID
- Local 2020/JF1
- Acronym
- COVID-19 ULD
- Status last verified
- Mar 2021
- First submitted
- 10 Mar 2021
- Last updated
- 12 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Patients Suspected of COVID 19 With Ultra Low Dose Thoracic Scanner
- ClinicalTrials.gov ID
- NCT04794361
- Acronym / sponsor ID
- COVID-19 ULD / Local 2020/JF1
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 5 Mar 2020 (actual)
- Primary completion
- 5 May 2020 (actual)
- Study completion
- 5 May 2020 (actual)
- First posted
- 12 Mar 2021 (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 year 2020 was marked by the emergence of a new respiratory disease: COVID19 related to an infection with the coronavirus SARS-CoV-2 (name given by the WHO on February 11, 2020). Initially appearing in China, in the province of Hubei, this epidemic has rapidly spread to be declared a global pandemic on March 12, 2020 by the WHO.Given the current context of the COVID-19 epidemic, strict hygiene measures have been taken in scanning rooms with systematic bio-cleaning. Strategies have been modified as a matter of urgency, with changes in the practices of electro radiology manipulators who work in "isolation" to avoid contamination. The number of scanners has increased exponentially following the curve of the epidemic, making it more and more difficult to systematically check the images before the patient leaves the room. To ensure sufficient image quality for interpretation of all scans, a complementary acquisition in ULD, with very low exposure, was systematically added to the acquisition protocol. The standard acquisition in LD, associated with this acquisition in ULD remain well below the diagnostic reference thresholds dictated by the nuclear safety authority (NRD: 350 mGy.cm. In Nîmes: LD: 100 to 150 mGy.cm and ULD: < 15 mGy.cm). These two acquisitions allow us to avoid breathing and movement artifacts, etc., without having to have the patients return for a new scan in case of a bad acquisition. This avoids an overexposure of the staff to the risk of infection by the SARS-CoV-2 virus.
The main objective of this retrospective study is to evaluate the diagnostic performance of ULD vs. LD for the accurate diagnosis of COVID-19 pneumopathy which presents a particular ground glass pattern
Our study will demonstrate that the ULD scanner can be used in the search for COVID-19 pneumopathy and thus limit the exposure of patients to X-rays, especially since thoracic scans are often repeated.
Detailed description
Main objective To evaluate the diagnostic performance of ULD vs. LD scanning for the diagnosis of COVID-19 lung disease.
Primary endpoint LD and ULD acquisitions will be anonymized and randomized in a read list. Double reading of scans in a randomized and blinded manner of the results of LD and ULD acquisitions of chest scans performed for suspected COVID-19 by 2 radiologists (one junior and one senior). Scans will be classified as non-COVID and COVID. The reference will be the LD scan. In case of discrepancy, a third senior radiologist will be asked and the decision will be made by consensus.
Secondary objectives
- Objective evaluation of image quality (signal, noise, contrast to noise ratio)
- Subjective evaluation of image quality and confidence in interpretation.
- Specific study of ground glass signal in ULD
Secondary evaluation criteria
- Measurement of signal and noise in the image using ROIs positioned in the lung, trachea, fat, which measure the average signal intensity and its standard deviation. These measurements will be performed on LD and ULD acquisitions at the same locations.
- Likert scale to subjectively assess image quality and confidence in the diagnosis.
- Specific measurement of signal and noise in the ground glass using ROI positioned within the ground glass that measures the average signal intensity and its standard deviation. This measurement will be performed on LD and ULD acquisitions at the same location.
Population concerned Patients of the Nîmes University Hospital who have had a prescription for a thoracic CT scan for suspected COVID-19 since March 5, 2020 (beginning of the COVID-19 protocol) and until April 5. Patients having had the LD and ULD acquisitions.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients from the Nîmes University Hospital who had a chest CT prescription for suspected COVID-19 since March 5, 2020 (start of the COVID-19 protocol) and until April 5
Key inclusion criteria (1 listed)
- Patients having had the LD and ULD acquisitions
Key exclusion criteria (1 listed)
- scanner not passed through the COVID circuit, no ULD acquisition performed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
reading of LD and ULD acquisitions
Time frame: day 1
Diagnostic performance of ULD vs LD scanner for the diagnosis of COVID-19 pneumopathy
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 12 Mar 2021.
Related trials for Covid19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19, run by Centre Hospitalier Universitaire de Nīmes at 1 site 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 1 inclusion and 1 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 12 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
reading of LD and ULD acquisitions (time frame: day 1). 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 12 Mar 2021.