Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by University of Arkansas
Information provided by (Responsible Party):
University of Arkansas Identifier:
First received: October 18, 2013
Last updated: October 17, 2016
Last verified: October 2016
To determine if Fluorescein systemic injection during hysterectomy procedure can be useful in revealing the depth of endometrial cancer invasion.

Condition Intervention Phase
Endometrial Cancer
Drug: Fluorescein
Phase 0

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Pilot Study to Determine the Efficacy of Fluorescein Visualization of the Uterus in Detecting Endometrial Cancer Invasion

Resource links provided by NLM:

Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • Efficacy of using fluorescein dye to determine depth of invasion compared to using frozen section and final pathology. [ Time Frame: 21 days ] [ Designated as safety issue: No ]
    For each study subject the paired difference in invasion depths determined using the Systemic Fluorescein Injection (SFI) versus Frozen Section (FS) methods will calculated and expressed as a percentage of the FS-based invasion depth.

Estimated Enrollment: 20
Study Start Date: September 2014
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
Drug: Fluorescein


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01979003

Contact: Alexander Burnett, MD 501-296-1099
Contact: Cynthia Walton 501-686-8274

United States, Arkansas
University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Alexander Burnett, MD    501-296-1099   
Contact: Cynthia Walton    501-686-8274   
Sponsors and Collaborators
University of Arkansas
Principal Investigator: Alexander Burnett, MD University of Arkansas
  More Information

Responsible Party: University of Arkansas Identifier: NCT01979003     History of Changes
Other Study ID Numbers: 202459 
Study First Received: October 18, 2013
Last Updated: October 17, 2016
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Diseases
Genital Diseases, Female processed this record on October 21, 2016