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

NCT01979003 | Completed Early Phase 1 Results

• 1 other identifier: 202459
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Endometrial Cancer

Outcome Measures

Primary Outcomes (1)

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

  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.

  1 day

Study Arms (1)

Fluorescein Injection

EXPERIMENTAL

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.

Drug: Fluorescein

Interventions

Fluorescein DRUG

Fluorescein Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years of age or older

You may not qualify if:

• Prior hysterectomy
• Known sensitivity to fluorescein dye

Sponsors & Collaborators

• University of Arkansas: lead

Study Sites (1)

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205, United States

Location

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Fluorescein

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Fluoresceins; Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Xanthenes; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Polycyclic Compounds

Limitations and Caveats

The protocol was updated and the other outcome measures are no longer part of the study, so they were removed. Deleted outcome measures were not pre-specified primary or secondary outcome measures.

Results Point of Contact

• Title: Alexander Burnett
• Organization: University of Arkansas for Medical Sciences

aburnett@uams.edu

5016868274

Study Officials

• Alexander Burnett, MD

  University of Arkansas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2013
• First Posted: November 8, 2013
• Study Start: September 1, 2014
• Primary Completion: October 2, 2019
• Study Completion: June 30, 2021
• Last Updated: February 24, 2022
• Results First Posted: December 10, 2021

Record last verified: 2021-11

Locations

US (1)