Early Phase 1
Completed N=100
Efficacy of Fluorescein Visualization of the Uterus in Detecting Endometrial Cancer Invasion
Source: ClinicalTrials.gov NCT01979003 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Dec 2021
Primary outcomePrimary: Percentage of Participants With Positive Predictive Value and Negative Predictive Value From Fluorescein Visualization — 71; 100; 85; 90 percentage of participants
Summary
To determine if Fluorescein systemic injection during hysterectomy procedure can be useful in revealing the depth of endometrial cancer invasion.
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 | — |
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. Informational only — not medical advice.