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Completed

NCT Number: NCT01979003

Efficacy of Fluorescein Visualization of the Uterus in Detecting Endometrial Cancer Invasion

To determine if Fluorescein systemic injection during hysterectomy procedure can be useful in revealing the depth of endometrial cancer invasion.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

About this study

All research participants will receive fluorescein injection through their existing intravenous line during their operative procedure for endometrial cancer staging. This will consist of one ampule (5 cc) injected intravenously prior to ligation of the uterine arteries. After the uterus is removed it will be sent to surgical pathology for evaluation as per routine care. The pathologist will open the uterus and evaluate the endometrium. He or she will then cut into the myometrium in an area most suspicious for invasion. The cross section of the myometrium and endometrium will be photographed while exposed to a Woods lamp. The normal myometrium will have a yellow fluorescent appearance under the Woods lamp. The cancerous tissue will have minimal fluorescence. The measurement will be taken estimating the depth of invasion of the cancer into the myometrium on the basis of its physical appearance under the Woods lamp. Cross-sectioning of the uterus is routine procedure by pathology for the intra-operative evaluation of endometrial cancer. This information routinely is provided in order to determine if lymph node staging is necessary.

The area that was measured and photographed will then be prepared for a frozen section to document depth of invasion. This is the standard procedure performed during an endometrial staging. The depth of invasion on the frozen section will be recorded. This same area will undergo histologic confirmation by permanent pathology to determine depth of invasion. The frozen section is part of routine standard of care in evaluation of endometrial cancer.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluorescein

Drug

Primary outcomes

  1. Percentage of Participants With Positive Predictive Value and Negative Predictive Value From Fluorescein Visualization

    Time frame: 1 day

    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.

Sponsors and collaborators

Lead sponsor

University of Arkansas

Other

Registry information

Official study title

A Pilot Study to Determine the Efficacy of Fluorescein Visualization of the Uterus in Detecting Endometrial Cancer Invasion

Important dates

Study start
2014
Primary completion
2019
Study completion
2021
First posted
Nov 8, 2013
Registry last updated
Feb 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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