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To determine if Fluorescein systemic injection during hysterectomy procedure can be useful in revealing the depth of endometrial cancer invasion.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fluorescein Injection | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluorescein | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alexander Burnett, MD | University of Arkansas | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arkansas for Medical Sciences | Little Rock | Arkansas | 72205 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | percentage of participants | 1 day |
|
On day of assessment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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The protocol was updated and the other outcome measures are no longer part of the study, so they were removed. Deleted outcome measures were not pre-specified primary or secondary outcome measures.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alexander Burnett | University of Arkansas for Medical Sciences | 5016868274 | aburnett@uams.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 28, 2016 | Aug 25, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D019793 | Fluorescein |
| ID | Term |
|---|---|
| D005452 | Fluoresceins |
| D013141 | Spiro Compounds |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 100 |
| 0 |
| 100 |
| 0 |
| 100 |
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| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D009930 |
| Organic Chemicals |
| D014966 | Xanthenes |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |