Endometrial Cancer
Conditions
Keywords
Endometrial Cancer, Robotic-Assisted Staging
Brief summary
This clinical trial studies lymph node mapping in patients with endometrial cancer. Lymph node mapping may allow for limited removal of lymph nodes in as part of endometrial cancer staging and treatment.
Detailed description
PRIMARY OBJECTIVE: I. To estimate the negative predictive value of pelvic sentinel lymph node (SLN) in endometrial cancer to predict nodal metastasis. SECONDARY OBJECTIVE: II. To examine the ability of sentinel lymph nodes to increase the detection of metastatic disease through ultra-sectioning and immuno-histochemical (IHC) staining by comparing IHC results and standard hematoxylin and eosin (H&E) results. OUTLINE: Patients undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue and sentinel lymph node biopsy and detection of sentinel lymph nodes is noted in the within 30 minutes of injection of the dye, followed by full pelvic lymph node dissection and aortic lymph node dissection as indicated, and standard hysterectomy and salpingo-oophorectomy. After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years for a total of 5 years according to the standard surveillance guidelines for endometrial cancer.
Interventions
PROCEDUREsentinel lymph node detection
Undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue
Undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue
DRUGisosulfan blue
Undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue
PROCEDUREsentinel lymph node biopsy
Undergo sentinel lymph node biopsy
Sponsors
Ohio State University Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* The patient must be willing and able to provide informed consent * The patient is willing and able to comply with the study protocol * The patient has endometrial cancer and is scheduled for robotic hysterectomy and lymphadenectomy * The patient agrees to follow-up examinations out to 5-years post-treatment
Exclusion criteria
* The patient is not a candidate for robotic assisted hysterectomy and lymphadenectomy * The patient has known or suspected allergies to iodine, indocyanine green (ICG) or isosulfan blue (ISB) * The patient has hepatic dysfunction confirmed by bilirubin \> 2 x normal (based on reference values from the laboratory used by the patient)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Negative Predictive Value of Sentinel Lymph Node Prediction of Metastatic Disease | average of 1-14 days after the procedure when final pathologic evaluation has been completed | NPV is found by dividing the number of true negatives by the number of all patients without pelvic lymph node metastases. Exact 95% confidence intervals (CIs) for the proportions will be calculated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Metastatic Cases Found Using Ultra-sectioning and IHC Staining | average of 1-14 days after the procedure when final pathologic evalulation has been completed | The percentage of metastatic cases analyzed by H&E will be compared to those of H&E-plus- IHC/ultrastaging using a z-test. |
Countries
United States
Participant flow
Recruitment details
The study opened in February 2013 and patients were enrolled between March 2013 and November 2016
Participants by arm
| Arm | Count |
|---|---|
| Sentinel Lymph Node Detection Patients undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue and sentinel lymph node biopsy. | 204 |
| Total | 204 |
Baseline characteristics
| Characteristic | Sentinel Lymph Node Detection |
|---|---|
| Age, Continuous | 60 years |
| Body Mass Index (BMI) | 36.5 kg/m^2 |
| Region of Enrollment United States | 204 participants |
| Sex: Female, Male Female | 204 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 204 |
| other Total, other adverse events | 0 / 204 |
| serious Total, serious adverse events | 0 / 204 |
Outcome results
Primary
Negative Predictive Value of Sentinel Lymph Node Prediction of Metastatic Disease
NPV is found by dividing the number of true negatives by the number of all patients without pelvic lymph node metastases. Exact 95% confidence intervals (CIs) for the proportions will be calculated.
Time frame: average of 1-14 days after the procedure when final pathologic evaluation has been completed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sentinel Lymph Node Detection | Negative Predictive Value of Sentinel Lymph Node Prediction of Metastatic Disease | 98.8 percentage of patients |
Secondary
Percentage of Metastatic Cases Found Using Ultra-sectioning and IHC Staining
The percentage of metastatic cases analyzed by H&E will be compared to those of H&E-plus- IHC/ultrastaging using a z-test.
Time frame: average of 1-14 days after the procedure when final pathologic evalulation has been completed
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sentinel Lymph Node Detection | Percentage of Metastatic Cases Found Using Ultra-sectioning and IHC Staining | 17 percentage of patients with positive LN |