Efficacy of Fluorescein Visualization of the Uterus in Detecting Endometrial Cancer Invasion
Study Details
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 |
|---|---|---|
| Early Phase 1 |
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 Design
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
- Percentage of Participants With Positive Predictive Value and Negative Predictive Value From Fluorescein Visualization [1 day]
Cancerous tissue will be measured to estimate the depth of invasion on the basis of physical appearance after receiving fluorescein injection prior to surgery. For each study subject, the paired difference in invasion depths determined using the Systemic Fluorescein Injection (SFI) versus Frozen Section (FS) methods will be calculated and expressed as a percentage of the FS-based invasion depth.
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Arkansas for Medical Sciences | Little Rock | Arkansas | United States | 72205 |
Sponsors and Collaborators
- University of Arkansas
Investigators
- Principal Investigator: Alexander Burnett, MD, University of Arkansas
Study Documents (Full-Text)
More Information
Publications
None provided.- 202459
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Fluorescein Injection |
|---|---|
| Arm/Group 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. Fluorescein |
| Period Title: Overall Study | |
| STARTED | 100 |
| COMPLETED | 72 |
| NOT COMPLETED | 28 |
Baseline Characteristics
| Arm/Group Title | Fluorescein Injection |
|---|---|
| Arm/Group 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. Fluorescein |
| Overall Participants | 100 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
63
63%
|
| >=65 years |
37
37%
|
| Age (years) [Mean (Full Range) ] | |
| Mean (Full Range) [years] |
62.53
|
| Sex: Female, Male (Count of Participants) | |
| Female |
100
100%
|
| Male |
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
17
17%
|
| White |
78
78%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
5
5%
|
| Region of Enrollment (participants) [Number] | |
| United States |
100
100%
|
Outcome Measures
| Title | Percentage of Participants With Positive Predictive Value and Negative Predictive Value From Fluorescein Visualization |
|---|---|
| Description | Cancerous tissue will be measured to estimate the depth of invasion on the basis of physical appearance after receiving fluorescein injection prior to surgery. For each study subject, the paired difference in invasion depths determined using the Systemic Fluorescein Injection (SFI) versus Frozen Section (FS) methods will be calculated and expressed as a percentage of the FS-based invasion depth. |
| Time Frame | 1 day |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Fluorescein Injection |
|---|---|
| Arm/Group 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. Fluorescein |
| Measure Participants | 72 |
| Fluorescein Positive Predictive Value |
71
71%
|
| Frozen section Positive Predictive Value |
100
100%
|
| Fluorescein Negative Predictive Value |
85
85%
|
| Frozen section Negative Predictive Value |
90
90%
|
Adverse Events
| Time Frame | On day of assessment. | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | Fluorescein Injection | |
| Arm/Group 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. Fluorescein | |
All Cause Mortality |
||
| Fluorescein Injection | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/100 (0%) | |
Serious Adverse Events |
||
| Fluorescein Injection | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/100 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Fluorescein Injection | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/100 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Alexander Burnett |
|---|---|
| Organization | University of Arkansas for Medical Sciences |
| Phone | 5016868274 |
| aburnett@uams.edu |
- 202459