Trial Outcomes & Findings for Cone Beam CT for Diagnosis of Select Otorhinolaryngology (ENT) Indications at Lower Dose (NCT NCT01855425)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

96 participants

Primary outcome timeframe

11 months

Results posted on

2018-08-28

Participant Flow

Participant milestones

Participant milestones
Measure	Investigational CBCT Investigator orders Medical CT as part of Standard of Care. Subject consents to be in study and they are also given a Cone Beam CT. Radiation: Subjects to receive standard of care CT scan and additional Cone Beam CT scan.
Overall Study STARTED	96
Overall Study COMPLETED	76
Overall Study NOT COMPLETED	20

Reasons for withdrawal

Reasons for withdrawal
Measure	Investigational CBCT Investigator orders Medical CT as part of Standard of Care. Subject consents to be in study and they are also given a Cone Beam CT. Radiation: Subjects to receive standard of care CT scan and additional Cone Beam CT scan.
Overall Study Physician Decision	20

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Investigational CBCT n=96 Participants Investigator orders CT as part of Standard of Care. Subject consents to be in study and they are also given a Cone Beam CT. Radiation: Subjects to receive standard of care CT scan and additional Cone Beam CT scan.
Age, Customized > 18 years - < 80 years	96 participants n=5 Participants
Sex: Female, Male Female	NA Participants n=5 Participants
Sex: Female, Male Male	NA Participants n=5 Participants
Region of Enrollment Belgium	32 participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants
Region of Enrollment France	45 participants n=5 Participants

PRIMARY outcome

Timeframe: 11 months

Population: 96 participants were imaged for this study, but only 76 participant image pairs were analyzed in the reader study. 20 participant image pairs were disqualified by the physicians due movement/unclear image quality.

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.

Outcome measures

Outcome measures
Measure	Investigational CBCT n=76 Participants Investigational CBCT images
Percentage of Participants With >=3 Diagnostic Rating Using Radlex Scale	92.63 percentage of participants Standard Deviation 4.9

Adverse Events

Investigational CBCT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Susan Pate, RN, MS, RAC

Carestream Health, Inc.

Phone: 585-627-6557

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place