Trial Outcomes & Findings for Efficacy of Fluorescein Visualization of the Uterus in Detecting Endometrial Cancer Invasion (NCT NCT01979003)
NCT ID: NCT01979003
Last Updated: 2022-02-24
Results Overview
Cancerous tissue will be measured to estimate the depth of invasion on the basis of physical appearance after receiving fluorescein injection prior to surgery. For each study subject, the paired difference in invasion depths determined using the Systemic Fluorescein Injection (SFI) versus Frozen Section (FS) methods will be calculated and expressed as a percentage of the FS-based invasion depth.
COMPLETED
EARLY_PHASE1
100 participants
1 day
2022-02-24
Participant Flow
Participant milestones
| Measure |
Fluorescein Injection
All research participants will receive fluorescein injection through existing intravenous line during the operative procedure. This will consist of one ampule (5 cc) injected intravenously 5- 10 minutes prior to ligation of the uterine arteries.
Fluorescein
|
|---|---|
|
Overall Study
STARTED
|
100
|
|
Overall Study
COMPLETED
|
72
|
|
Overall Study
NOT COMPLETED
|
28
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of Fluorescein Visualization of the Uterus in Detecting Endometrial Cancer Invasion
Baseline characteristics by cohort
| Measure |
Fluorescein Injection
n=100 Participants
All research participants will receive fluorescein injection through existing intravenous line during the operative procedure. This will consist of one ampule (5 cc) injected intravenously 5- 10 minutes prior to ligation of the uterine arteries.
Fluorescein
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
63 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
37 Participants
n=39 Participants
|
|
Age, Continuous
|
62.53 years
n=39 Participants
|
|
Sex: Female, Male
Female
|
100 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=39 Participants
|
|
Race (NIH/OMB)
White
|
78 Participants
n=39 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
100 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: 1 dayCancerous tissue will be measured to estimate the depth of invasion on the basis of physical appearance after receiving fluorescein injection prior to surgery. For each study subject, the paired difference in invasion depths determined using the Systemic Fluorescein Injection (SFI) versus Frozen Section (FS) methods will be calculated and expressed as a percentage of the FS-based invasion depth.
Outcome measures
| Measure |
Fluorescein Injection
n=72 Participants
All research participants will receive fluorescein injection through existing intravenous line during the operative procedure. This will consist of one ampule (5 cc) injected intravenously 5- 10 minutes prior to ligation of the uterine arteries.
Fluorescein
|
|---|---|
|
Percentage of Participants With Positive Predictive Value and Negative Predictive Value From Fluorescein Visualization
Fluorescein Positive Predictive Value
|
71 percentage of participants
|
|
Percentage of Participants With Positive Predictive Value and Negative Predictive Value From Fluorescein Visualization
Frozen section Positive Predictive Value
|
100 percentage of participants
|
|
Percentage of Participants With Positive Predictive Value and Negative Predictive Value From Fluorescein Visualization
Fluorescein Negative Predictive Value
|
85 percentage of participants
|
|
Percentage of Participants With Positive Predictive Value and Negative Predictive Value From Fluorescein Visualization
Frozen section Negative Predictive Value
|
90 percentage of participants
|
Adverse Events
Fluorescein Injection
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Alexander Burnett
University of Arkansas for Medical Sciences
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place