Tin X RayNCT04119141
Benefit of Tin Filter in Regards to Image Quality and Radiation Dose in CT Scan Study of Pulmonary Parenchyma
A study testing X ray imaging in people with Tin X Ray and Pulmonary Parenchyma, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
Main objective: to demonstrate that the diagnostic quality associated with the acquisition mode with tin filter, evaluated in a subjective way, is not inferior to that associated with the acquisition mode without filter. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tin X Ray, Pulmonary Parenchyma
- What is being tested?
- X ray imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- 10 May 2019to 30 Jun 2020
- 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
- Patient aged 18 and over.
- Patient referred for chest CT scan in the context of screening or monitoring of occupational exposure to asbestos.
- Patient with health insurance or beneficiary of a social security scheme.
- Patient having given their express consent.
Who cannot join
- Woman who is pregnant or likely to be pregnant.
- Lactating or parturient women
- Minors.
- Protected patients: Adults under trusteeship, guardianship or other legal protection, deprived of liberty by judicial or administrative decision; hospitalised without consent.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital Privé d'Antony Antony
Antony, IDF, 92160
Jean Francois OUDET, +33683346567 ext. +33683346567, jf.oudet@ecten.eu
Marie Barba, +330664888704 ext. +330664888704, mh.barba@ecten.eu
About this study
Official title: Benefit of Tin Filter in Regards to Image Quality and Radiation Dose in CT Scan
Main objective: to demonstrate that the diagnostic quality associated with the acquisition mode with tin filter, evaluated in a subjective way, is not inferior to that associated with the acquisition mode without filter.
Read the detailed description
The chest x-ray is the first-line exam for the study of pulmonary parenchyma. Nevertheless, it does not make it possible to reveal all pulmonary pathologies, and in particular those of very small sizes. Thanks to its very high spatial resolution and contrast resolution, the scanner is able to detect all infra-millimetric pathologies of the pulmonary parenchyma but also mediastinal pathologies that could not have been seen on the standard x-ray.
This study fits into the context of pleural pathology screening for patients exposed to asbestos in their professional environment.
Today, the chest CT scan in millimetric sections isth e standardised method used in the context of this screening.Tin filtration is an additional filtration at the output of the X-ray tube made available on premium Siemens scanners. In diagnostic medical imaging, the photon beam has an energetic spectrum ranging from 0 to 150 keV. However the weak energies do not participate in the formation of the image but, on the other hand, to the overall radiation of the patient. The purpose of the addition of the tin filter is to be able to suppress, at the output of the tube, all low and medium energy levels, only allowing high energy levels to pass through. A previous study comparing the same group of patients on two different machines (one with tin filtration, one without tin filtration) showed a significant decrease in the radiation dose; nevertheless, a certain number of parameters differed between the two scanners used. In order to get rid of the different biases encountered on previous published studies, we propose to carry out this study on the same machine, by activating and deactivating tin filtration, all other parameters of acquisition and reconstruction of the image being equal in all respects.
- Conditions
- Tin X Ray, Pulmonary Parenchyma
- Being tested
- X ray imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
X ray imagingDiagnostic test
Acquisition:
- 140 kVp,
- 1/2 mAs/kg,
- Pitch: 1.35,
- Rotation time: 0.5 sec.
Reconstruction:
- I70f filter, 3 iteration loops,
- Cutting thickness 1 mm/0.7 mm
- Fenestration: C -600/W 1600
- Field of view (Size, x \& y coordinates) identical on both acquisitions.
| Study group | Role | What they receive |
|---|---|---|
| Standard Arm | Active comparator | the first acquisition will be carried out without a tin filter in supine position and the second with tin filter in procubitus. Receives: Diagnostic Test: X ray imaging |
| Tin filter Arm | Experimental | the first acquisition will be carried out with tin filter in supine position and the second without tin filter in procubitus. Receives: Diagnostic Test: X ray imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Likert score scale score
Primary endpoint: score obtained on the Likert scale.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start10 May 2019
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tin X RayStudies of the same condition, open and under way.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Dr Béatrice Daoud
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04119141
- Sponsor's protocol ID
- 2018-A00918-47
- Status last verified
- Oct 2019
- First submitted
- 3 Oct 2019
- Last updated
- 8 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefit of Tin Filter in Regards to Image Quality and Radiation Dose in CT Scan
- ClinicalTrials.gov ID
- NCT04119141
- Acronym / sponsor ID
- 2018-A00918-47
- Conditions
- Tin X Ray, Pulmonary Parenchyma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- Dr Béatrice Daoud
- Study start
- 10 May 2019 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 8 Oct 2019 (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.
Main objective: to demonstrate that the diagnostic quality associated with the acquisition mode with tin filter, evaluated in a subjective way, is not inferior to that associated with the acquisition mode without filter.
Detailed description
The chest x-ray is the first-line exam for the study of pulmonary parenchyma. Nevertheless, it does not make it possible to reveal all pulmonary pathologies, and in particular those of very small sizes. Thanks to its very high spatial resolution and contrast resolution, the scanner is able to detect all infra-millimetric pathologies of the pulmonary parenchyma but also mediastinal pathologies that could not have been seen on the standard x-ray.
This study fits into the context of pleural pathology screening for patients exposed to asbestos in their professional environment.
Today, the chest CT scan in millimetric sections isth e standardised method used in the context of this screening.Tin filtration is an additional filtration at the output of the X-ray tube made available on premium Siemens scanners. In diagnostic medical imaging, the photon beam has an energetic spectrum ranging from 0 to 150 keV. However the weak energies do not participate in the formation of the image but, on the other hand, to the overall radiation of the patient. The purpose of the addition of the tin filter is to be able to suppress, at the output of the tube, all low and medium energy levels, only allowing high energy levels to pass through. A previous study comparing the same group of patients on two different machines (one with tin filtration, one without tin filtration) showed a significant decrease in the radiation dose; nevertheless, a certain number of parameters differed between the two scanners used. In order to get rid of the different biases encountered on previous published studies, we propose to carry out this study on the same machine, by activating and deactivating tin filtration, all other parameters of acquisition and reconstruction of the image being equal in all respects.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Arm | Active comparator | Diagnostic Test: X ray imagingthe first acquisition will be carried out without a tin filter in supine position and the second with tin filter in procubitus. |
| Tin filter Arm | Experimental | Diagnostic Test: X ray imagingthe first acquisition will be carried out with tin filter in supine position and the second without tin filter in procubitus. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient aged 18 and over.
- Patient referred for chest CT scan in the context of screening or monitoring of occupational exposure to asbestos.
- Patient with health insurance or beneficiary of a social security scheme.
- Patient having given their express consent.
Key exclusion criteria (4 listed)
- Woman who is pregnant or likely to be pregnant.
- Lactating or parturient women
- Minors.
- Protected patients: Adults under trusteeship, guardianship or other legal protection, deprived of liberty by judicial or administrative decision; hospitalised without consent.
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 |
|---|---|---|
| X ray imagingAcquisition: * 140 kVp, * 1/2 mAs/kg, * Pitch: 1.35, * Rotation time: 0.5 sec. Reconstruction: * I70f filter, 3 iteration loops, * Cutting thickness 1 mm/0.7 mm * Fenestration: C -600/W 1600 * Field of view (Size, x \& y coordinates) identical on both acquisitions. | Diagnostic test | Standard Arm, Tin filter Arm |
Primary outcome
Likert score scale score
Time frame: 1 hour
Primary endpoint: score obtained on the Likert scale.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2019.
- Individual participant dataSharing planned: Undecided
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing X ray imaging in people with Tin X Ray and Pulmonary Parenchyma, run by GCS Ramsay Santé pour l'Enseignement et la Recherche 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 8 Oct 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean Francois OUDET (+33683346567, jeanfrancois.oudet@free.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Likert score scale score (time frame: 1 hour). 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 8 Oct 2019.