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Benefit of Tin Filter in Regards to Image Quality and Radiation Dose in CT Scan Study of Pulmonary Parenchyma

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ClinicalTrials.gov Identifier: NCT04119141
Recruitment Status : Unknown
Verified October 2019 by Ramsay Générale de Santé.
Recruitment status was:  Recruiting
First Posted : October 8, 2019
Last Update Posted : October 8, 2019
Sponsor:
Collaborator:
Dr Béatrice Daoud
Information provided by (Responsible Party):
Ramsay Générale de Santé

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Tin X Ray Pulmonary Parenchyma Diagnostic Test: X ray imaging Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Device Feasibility
Official Title: Benefit of Tin Filter in Regards to Image Quality and Radiation Dose in CT Scan
Actual Study Start Date : May 10, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: X-Rays
Drug Information available for: X-Rays

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Standard Arm
the first acquisition will be carried out without a tin filter in supine position and the second with tin filter in procubitus.
 Diagnostic Test: X ray imaging

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.
Experimental: Tin filter Arm
the first acquisition will be carried out with tin filter in supine position and the second without tin filter in procubitus.
 Diagnostic Test: X ray imaging

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.


Outcome Measures
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Primary Outcome Measures :
  1. Likert score scale score [ Time Frame: 1 hour ]
    Primary endpoint: score obtained on the Likert scale.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04119141


Contacts
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Contact: Jean Francois OUDET +33683346567 jeanfrancois.oudet@free.fr
Contact: Marie Barba +330664888704 ext +330664888704 mh.barba@ecten.eu

Locations
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France
Hôpital Privé d'Antony Antony Recruiting
Antony, IDF, France, 92160
Contact: Jean Francois OUDET    +33683346567 ext +33683346567    jf.oudet@ecten.eu   
Contact: Marie Barba    +330664888704 ext +330664888704    mh.barba@ecten.eu   
Sponsors and Collaborators
Ramsay Générale de Santé
Dr Béatrice Daoud
More Information
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Responsible Party: Ramsay Générale de Santé
ClinicalTrials.gov Identifier: NCT04119141    
Other Study ID Numbers: 2018-A00918-47
First Posted: October 8, 2019    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No