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

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ClinicalTrials.gov Identifier: NCT01979003
Recruitment Status : Recruiting
First Posted : November 8, 2013
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):

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

Condition or disease Intervention/treatment Phase
Endometrial Cancer Drug: Fluorescein Early Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2014
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Efficacy of using fluorescein dye to determine depth of invasion compared to using frozen section and final pathology. [ Time Frame: 21 days ]
    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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01979003     History of Changes
Other Study ID Numbers: 202459
First Posted: November 8, 2013    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female