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

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.

Study Overview

• Status: Completed
• Conditions: Sinonasal Pathologies
• Intervention / Treatment: Radiation: Computed Tomography; Radiation: Cone Beam Computed Tomography

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31059
    • VERGEZ

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: patients with sinonasal pathology; Computed Tomography Cone Beam Computed Tomography	Radiation: Computed Tomography; imagery with ionizing radiation; Radiation: Cone Beam Computed Tomography; imagery with ionizing radiation

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
morphological concordance between cone beam and CT	Assessment of the morphological concordance between the CT and the Cone Beam in the sinus imagery with these 26 items assessed separately	1 day
reproductibility INTER-OBSERVER	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	1 day
dosimetry	Assessment of the dosimetry CT/ Cone Beam	1 day
Diagnosis concordance radio-endoscopic and radio-surgical	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.	1 day

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Sebastien VERGEZ, PhD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: March 4, 2015
• First Submitted That Met QC Criteria: March 23, 2015
• First Posted (Estimate): March 24, 2015

Study Record Updates

• Last Update Posted (Estimate): October 26, 2016
• Last Update Submitted That Met QC Criteria: October 24, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Other Study ID Numbers: 13 147 03; 2013-A00736-39 (Registry Identifier: ANSM)