Back to resultsCone Beam CT for Diagnosis of Select Otorhinolaryngology (ENT) Indications at Lower Dose (CBCT-ENT)
Primary Purpose
CerebroSpinal Fluid (CSF) Leak, Chronic Otitis Media, Otospongiosis
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Radiation
Sponsored by
About this trial
This is an interventional diagnostic trial for CerebroSpinal Fluid (CSF) Leak
Eligibility Criteria
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- Subjects not willing to consent, or consent is withdrawn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
Sites / Locations
- Johns Hopkins Medical Center
- Sint-Augustinus Hospital
- C.H.U Bicetre
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Investigational CBCT
Arm Description
Radiation
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01855425
Brief Title
Cone Beam CT for Diagnosis of Select Otorhinolaryngology (ENT) Indications at Lower Dose
Acronym
CBCT-ENT
Official Title
Cone Beam CT (CS 9300) for Diagnosis of Select Otorhinolaryngology (ENT) Indications at Lower Dose
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
September 21, 2012 (Actual)
Primary Completion Date
August 9, 2013 (Actual)
Study Completion Date
August 9, 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Carestream Health, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study objective is to compare the CBCT images generated by the CS 9300 to those generated by conventional CT.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CerebroSpinal Fluid (CSF) Leak, Chronic Otitis Media, Otospongiosis, Otosclerosis, Pulsatile Tinnitus, Cholesteatoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Predicate CT Scan and Investigational Cone Beam Scan
Masking
None (Open Label)
Allocation
N/A
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Investigational CBCT
Arm Type
Other
Arm Description
Radiation
Intervention Type
Radiation
Intervention Name(s)
Radiation
Intervention Description
Subjects to receive standard of care CT scan and additional Cone Beam CT scan.
Primary Outcome Measure Information:
Title
Percentage of Participants With >=3 Diagnostic Rating Using Radlex Scale
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas Reh, MD
Organizational Affiliation
Johns Hopkins Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Sint-Augustinus Hospital
City
Antwerp
Country
Belgium
Facility Name
C.H.U Bicetre
City
Paris
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cone Beam CT for Diagnosis of Select Otorhinolaryngology (ENT) Indications at Lower Dose
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