Cone Beam CT for Diagnosis of Select Otorhinolaryngology (ENT) Indications at Lower Dose

Carestream Health, Inc.96 enrolled

Overview

The study objective is to compare the CBCT images generated by the CS 9300 to those generated by conventional CT.

The study objective is to compare the CBCT images generated by the CS 9300 to those generated by conventional CT. It proposes a direct comparison of diagnostic image quality between the CS 9300 and CT for the ability to view and confirm ENT disorders.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

CerebroSpinal Fluid (CSF) Leak Chronic Otitis Media Otospongiosis Otosclerosis Pulsatile Tinnitus Cholesteatoma

Interventions

RadiationRADIATION

Subjects to receive standard of care CT scan and additional Cone Beam CT scan.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subject must be 18-80 years of age * Subjects has provided informed consent * Subjects must present with symptoms and/or pathology of the sinus or temporal bone region. * Subject scheduled for additional radiological follow-up and/or endoscopy/surgery. * CBCT exam performed within a maximum of 2 days of the conventional CT. Exclusion Criteria: * Subjects under the age of 18 years, or over the age of 80 years * Unable to collect all required case information * Subjects not willing to consent, or consent is withdrawn * Women in pregnancy or suspected of being pregnant confirmed by pregnancy test

Locations (3)

Johns Hopkins Medical Center

Baltimore, Maryland, United States

Sint-Augustinus Hospital

Antwerp, Belgium

C.H.U Bicetre

Paris, France

Outcomes

Primary Outcomes

Percentage of Participants With >=3 Diagnostic Rating Using Radlex Scale

Percentage of Participants with \>=3 Diagnostic Rating Using Radlex Scale. Five radiologists participated in reader study using Radlex scale below to analyze and rate participant images. They determined if they could make a medical diagnosis for ENT patients. Used Radlex Scale - 1-Non-diagnostic, Unacceptable for diagnostic purposes. 2-Limited Acceptable, with some technical defect. 3-Diagnostic, Image quality that would be expected routinely when imaging cooperative patients. 4-Exemplary, Good most adequate for diagnostic purposes.

Time frame: 11 months

Data from ClinicalTrials.gov

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