Early Phase 1
N=100
Efficacy of Fluorescein Visualization of the Uterus in Detecting Endometrial Cancer Invasion
Endometrial Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01979003 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Dec 2021
Primary outcome: Primary: Percentage of Participants With Positive Predictive Value and Negative Predictive Value From Fluorescein Visualization — 71; 100; 85; 90 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Fluorescein (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Arkansas
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Positive Predictive Value and Negative Predictive Value From Fluorescein Visualization |
71; 100; 85; 90 | — |
Summary
To determine if Fluorescein systemic injection during hysterectomy procedure can be useful in revealing the depth of endometrial cancer invasion.
Eligibility Criteria
Inclusion Criteria
- Documented endometrial cancer and scheduled for hysterectomy as part of their treatment.
- No known allergy to fluorescein dye
- Ability to understand and sign informed consent
- 18 years of age or older
Exclusion Criteria
- Prior hysterectomy
- Known sensitivity to fluorescein dye
Data sourced from ClinicalTrials.gov (NCT01979003). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.