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Trial Outcomes & Findings for Standard PET/CT vs. Digital PET/CT (NCT NCT03081767)

NCT ID: NCT03081767

Last Updated: 2022-04-12

Results Overview

Diagnostic image quality will be determined using a 5-point Likert Scale that reads: 5 - Diagnostic: Excellent diagnostic image quality; 4 - Diagnostic: Good diagnostic image quality; 3 - Diagnostic: Acceptable diagnostic image quality; 2 - Sub-optimal diagnostic: image quality with limited additional clinical information; 1 - Non-diagnostic: non-diagnostic image quality

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

199 participants

Primary outcome timeframe

an expected average of 3 hours

Results posted on

2022-04-12

Participant Flow

Participant milestones

Participant milestones
Measure
Patients Undergoing Digital PET/CT
Patients referred to Nuclear Medicine undergo imaging on the standard positron emission tomography/computed tomography (PET/CT) and also have imaging performed on the digital PET/CT.
Overall Study
STARTED
199
Overall Study
COMPLETED
199
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Standard PET/CT vs. Digital PET/CT

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Patients Undergoing Digital PET/CT
n=199 Participants
Patients referred to Nuclear Medicine undergo imaging on the standard PET/CT and also have imaging performed on the digital PET/CT.
Age, Continuous
64.8 years
STANDARD_DEVIATION 10.9 • n=5 Participants
Sex: Female, Male
Female
55 Participants
n=5 Participants
Sex: Female, Male
Male
144 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
16 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
176 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
7 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
20 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
2 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
1 Participants
n=5 Participants
Race (NIH/OMB)
White
159 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
17 Participants
n=5 Participants
Region of Enrollment
United States
199 Participants
n=5 Participants

PRIMARY outcome

Timeframe: an expected average of 3 hours

Diagnostic image quality will be determined using a 5-point Likert Scale that reads: 5 - Diagnostic: Excellent diagnostic image quality; 4 - Diagnostic: Good diagnostic image quality; 3 - Diagnostic: Acceptable diagnostic image quality; 2 - Sub-optimal diagnostic: image quality with limited additional clinical information; 1 - Non-diagnostic: non-diagnostic image quality

Outcome measures

Outcome measures
Measure
Digital PET/CT
n=199 Participants
Imaging using digital PET/CT.
Standard PET/CT
n=199 Participants
Imaging using standard PET/CT.
Diagnostic Image Quality
4.96 score on a scale
Standard Deviation 0.20
4.30 score on a scale
Standard Deviation 0.47

Adverse Events

Digital PET/CT

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Standard PET/CT

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

Andrei Iagaru

Stanford University

Phone: 6507254711

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place