Endometrial Cancer
Conditions
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.
Interventions
DRUGFluorescein
Sponsors
University of Arkansas
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
Fluorescein | 100 |
| Total | 100 |
Baseline characteristics
| Characteristic | Fluorescein Injection |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 37 Participants |
| Age, Categorical Between 18 and 65 years | 63 Participants |
| Age, Continuous | 62.53 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 78 Participants |
| Region of Enrollment United States | 100 participants |
| Sex: Female, Male Female | 100 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 100 |
| other Total, other adverse events | 0 / 100 |
| serious Total, serious adverse events | 0 / 100 |
Outcome results
Primary
Percentage of Participants With Positive Predictive Value and Negative Predictive Value From Fluorescein Visualization
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluorescein Injection | Percentage of Participants With Positive Predictive Value and Negative Predictive Value From Fluorescein Visualization | Fluorescein Positive Predictive Value | 71 percentage of participants |
| Fluorescein Injection | Percentage of Participants With Positive Predictive Value and Negative Predictive Value From Fluorescein Visualization | Frozen section Positive Predictive Value | 100 percentage of participants |
| Fluorescein Injection | Percentage of Participants With Positive Predictive Value and Negative Predictive Value From Fluorescein Visualization | Fluorescein Negative Predictive Value | 85 percentage of participants |
| Fluorescein Injection | Percentage of Participants With Positive Predictive Value and Negative Predictive Value From Fluorescein Visualization | Frozen section Negative Predictive Value | 90 percentage of participants |