Assessment of the Morphological Concordance Between CT and Cone Beam in Sinus Imagery

Not Applicable

Completed

• Conditions: Sinonasal Pathologies
• Interventions: Radiation: Computed Tomography; Radiation: Cone Beam Computed Tomography

• Registration Number: NCT02397148
• Lead Sponsor: University Hospital, Toulouse

Brief Summary

This study compares the morphological concordance between CT (computed tomography) and cone beam in sinus on 26 validated items. CT and cone beam is performed on each patient. Performances of these two imagery technics seem to be closed. Nevertheless, the exposure of the ionizing radiations is lower with the cone beam.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-08
• Study First Submitted: 2015-03-04
• Study First Submitted QC: 2015-03-23
• Study First Posted: 2015-03-24
• Primary Completion: 2016-02
• Study Completion: 2016-02
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-24
• Last Update Posted: 2016-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• man or woman older than 18 years old
• patient affected by sinonasal pathology : who show one or more of the following functional sign : anosmia, pain with sinusal origin (frontal headache, lower-orbital throbbing pain increased in anteflexion, chronic unexplained headache), nasal blockage, runny nose, epistaxis requiring the realisation of a sinus imagery overview.

Exclusion Criteria

• Deprivation of liberty by administrative or legal decision
• patients under 18 years old
• Patients in emergency

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
patients with sinonasal pathology	Cone Beam Computed Tomography	Computed Tomography Cone Beam Computed Tomography
patients with sinonasal pathology	Computed Tomography	Computed Tomography Cone Beam Computed Tomography

Primary Outcome Measures

Name	Time	Method
intraclass correlation coefficient	1 day	Assessment of the morphological concordance between the CT and the Cone Beam in the sinus imagery with 26 validated items.

Secondary Outcome Measures

Name	Time	Method
morphological concordance between cone beam and CT	1 day	Assessment of the morphological concordance between the CT and the Cone Beam in the sinus imagery with these 26 items assessed separately
Diagnosis concordance radio-endoscopic and radio-surgical	1 day	Radio-endoscopic surgical concordance and radio will be estimated by calculating the proportion of concordant diagnoses between the radiological evaluation and cone beam scanner and endoscopic evaluation obtained at the first nasal endoscopy and radiological evaluation between the scanner and cone beam and intraoperative assessment in case of surgery. The investigators then compare the radio-endoscopic surgical concordance and radio and the cone beam scanner.
reproductibility INTER-OBSERVER	1 day	The reproducibility of the measurement between the two neuroradiologists will be assessed by intraclass correlation coefficient, based on 26 benchmarks of primary endpoint. Similarly inter-observer reproducibility will be assessed for the 36 specific criteria
dosimetry	1 day	Assessment of the dosimetry CT/ Cone Beam

Trial Locations

Locations (1)

VERGEZ; 🇫🇷 Toulouse, France