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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 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: May 12, 2014
Last verified: May 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: June 2014
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
  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 Not yet 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: May 12, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 18, 2014