Brief Title
A Pilot Study to Determine the Efficacy of Fluorescein Visualization of the Uterus in Detecting Endometrial Cancer Invasion
Official Title
A Pilot Study to Determine the Efficacy of Fluorescein Visualization of the Uterus in Detecting Endometrial Cancer Invasion
Brief Summary
To determine if Fluorescein systemic injection during hysterectomy procedure can be useful in
revealing the depth of endometrial cancer invasion.
Detailed Description
All research participants will receive fluorescein injection through their existing
intravenous line during their operative procedure for endometrial cancer staging. This will
consist of one ampule (5 cc) injected intravenously prior to ligation of the uterine
arteries. After the uterus is removed it will be sent to surgical pathology for evaluation as
per routine care. The pathologist will open the uterus and evaluate the endometrium. He or
she will then cut into the myometrium in an area most suspicious for invasion. The cross
section of the myometrium and endometrium will be photographed while exposed to a Woods lamp.
The normal myometrium will have a yellow fluorescent appearance under the Woods lamp. The
cancerous tissue will have minimal fluorescence. The measurement will be taken estimating the
depth of invasion of the cancer into the myometrium on the basis of its physical appearance
under the Woods lamp. Cross-sectioning of the uterus is routine procedure by pathology for
the intra-operative evaluation of endometrial cancer. This information routinely is provided
in order to determine if lymph node staging is necessary.
The area that was measured and photographed will then be prepared for a frozen section to
document depth of invasion. This is the standard procedure performed during an endometrial
staging. The depth of invasion on the frozen section will be recorded. This same area will
undergo histologic confirmation by permanent pathology to determine depth of invasion. The
frozen section is part of routine standard of care in evaluation of endometrial cancer.
Study Phase
Early Phase 1
Study Type
Interventional
Primary Outcome
Efficacy of using fluorescein dye to determine depth of invasion compared to using frozen section and final pathology.
Condition
Endometrial Cancer
Intervention
Fluorescein
Study Arms / Comparison Groups
Fluorescein Injection
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
100
Start Date
September 2014
Completion Date
October 2020
Primary Completion Date
October 2020
Eligibility 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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Alexander Burnett, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01979003
Organization ID
202459
Responsible Party
Sponsor
Study Sponsor
University of Arkansas
Study Sponsor
Alexander Burnett, MD, Principal Investigator, University of Arkansas
Verification Date
October 2019