Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02397148
Acronym
COSINUS
Enrollment
50
Registered
2015-03-24
Start date
2013-08-31
Completion date
2016-02-29
Last updated
2025-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sinonasal Pathologies

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.

Interventions

RADIATIONComputed Tomography

imagery with ionizing radiation

imagery with ionizing radiation

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
intraclass correlation coefficient1 dayAssessment of the morphological concordance between the CT and the Cone Beam in the sinus imagery with 26 validated items.

Secondary

MeasureTime frameDescription
morphological concordance between cone beam and CT1 dayAssessment of the morphological concordance between the CT and the Cone Beam in the sinus imagery with these 26 items assessed separately
reproductibility INTER-OBSERVER1 dayThe 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
dosimetry1 dayAssessment of the dosimetry CT/ Cone Beam
Diagnosis concordance radio-endoscopic and radio-surgical1 dayRadio-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.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026