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 September 2014 by University of Arkansas
Sponsor:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT01979003
First received: October 18, 2013
Last updated: September 23, 2014
Last verified: September 2014
  Purpose

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 2015
Estimated Primary Completion Date: September 2015 (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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  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 ClinicalTrials.gov identifier: NCT01979003

Contacts
Contact: Alexander Burnett, MD 501-296-1099 ABurnett@uams.edu
Contact: Cynthia Walton 501-686-8274 waltoncynthial@uams.edu

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

No publications provided

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01979003     History of Changes
Other Study ID Numbers: 202459
Study First Received: October 18, 2013
Last Updated: September 23, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Endometrial Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Uterine Diseases
Uterine Neoplasms
Fluorescein
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 21, 2014