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

NCT ID: NCT04119141

Last Updated: 2019-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-10

Study Completion Date

2020-06-30

Brief Summary

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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

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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

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Tin X Ray Pulmonary Parenchyma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Standard Arm

the first acquisition will be carried out without a tin filter in supine position and the second with tin filter in procubitus.

Group Type ACTIVE_COMPARATOR

X ray imaging

Intervention Type DIAGNOSTIC_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.

Tin filter Arm

the first acquisition will be carried out with tin filter in supine position and the second without tin filter in procubitus.

Group Type EXPERIMENTAL

X ray imaging

Intervention Type DIAGNOSTIC_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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr Béatrice Daoud

UNKNOWN

Sponsor Role collaborator

Ramsay Générale de Santé

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital Privé d'Antony Antony

Antony, IDF, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Jean Francois OUDET

Role: CONTACT

+33683346567

Marie Barba

Role: CONTACT

+330664888704 ext. +330664888704

Facility Contacts

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Jean Francois OUDET

Role: primary

+33683346567 ext. +33683346567

Marie Barba

Role: backup

+330664888704 ext. +330664888704

Other Identifiers

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2018-A00918-47

Identifier Type: -

Identifier Source: org_study_id

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