Stage I Endometrial Carcinoma, Stage II Endometrial Carcinoma, Stage III Endometrial Carcinoma, Stage IV Endometrial Carcinoma
Conditions
Brief summary
This clinical trial studies lymph node mapping in patients with newly diagnosed endometrial cancer undergoing surgery. Lymph node mapping may help in planning surgery to remove endometrial cancer and affected lymph nodes.
Detailed description
PRIMARY OBJECTIVES: I. To determine the detection rate, sensitivity, and negative predictive value of sentinel lymph node (SLN) biopsy in endometrial cancer patients. SECONDARY OBJECTIVES: I. To compare different surgical modalities (open procedures, minimally invasive procedures, and single-site technology) and different injectants (isosulfan blue and indocyanine green) for SLN biopsy. II. To determine total operating room time (from the time the patient enters the room to the time the patient leaves the room) as well as console time (robotic)/operating time for minimally invasive procedures. OUTLINE: Patients undergo SLN mapping using isosulfan blue and/or indocyanine green solution injected directly into the cervix. Following SLN identification and biopsy, patients undergo hysterectomy, bilateral salpingo-oophorectomy, and/or complete pelvic lymphadenectomy. Patients expressing SLN positive for metastasis undergo para-aortic lymphadenectomy. After completion of study treatment, patients are followed up at 2-4 weeks.
Interventions
PROCEDURElymph node mapping
Undergo lymph node mapping using isosulfan blue and/or indocyanine green solution
PROCEDUREsentinel lymph node biopsy
Undergo SLN biopsy
DRUGisosulfan blue
Undergo lymph node mapping using isosulfan blue and/or indocyanine green solution
Undergo lymph node mapping using isosulfan blue and/or indocyanine green solution
PROCEDUREtherapeutic conventional surgery
Undergo hysterectomy, bilateral salpingo-oophorectomy and/or complete pelvic lymphadenectomy
PROCEDURElymphadenectomy
Undergo para-aortic lymphadenectomy
Sponsors
Case Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Women must have newly diagnosed histologically or cytologically confirmed endometrial cancer * Women should have received no prior therapy for their disease * Women who are planning to undergo hysterectomy, bilateral salpingo-oophorectomy, and pelvic lymphadenectomy for the management of their endometrial cancer * Women must have the ability to understand and the willingness to sign a written informed consent document
Exclusion criteria
* Women who are receiving any other investigational agents * Women with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to isosulfan blue or indocyanine green or other agents used in this study * Women with hypersensitivity to phenylmethane compounds, or a history of allergic reaction to iodides * Patients with uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Women with a history of prior loop electrosurgical excision procedure (LEEP) or cone procedures performed on their cervix * Women with a history of lymphedema, lymphoma, or lymphatic hyperplasia (Castleman disease) * Women with a history of a prior malignancy * Women may also be excluded at the discretion of their surgeon if he or she feels that the patient is not an appropriate candidate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of True Positive SLN Identified With Surgical Modalities (Open Procedures, Minimally Invasive Procedures, and Single-site Technology) | Up to 4 weeks | The percent of true positive SLN identified with surgical modalities using pairwise comparisons for each surgical modality. Comparisons will be performed using two sample tests of proportions based on a normal approximation. |
| Number of Participants With Sentinel Nodes Per Side of Pelvis | Up to 4 weeks | Detection rate, as defined as number of participants with a sentinel node found per side of pelvis |
| False Negative Rate as Defined as Proportion of Participants With False Negative Detection | Up to 4 weeks | False negative rate = 1-sensitivity or the number of patients with a false negative SLN over the number of patients with a positive SLN plus those with a false negative lymph node |
| Sensitivity of Sentential Lymph Node (SLN) Biopsy | Up to 4 weeks | Sensitivity estimated as the proportion of true positives among participants with lymph node metastases. Sensitivity Calculation= the number of patients with a positive SLN over those patients with a positive SLN plus those patients with a false negative lymph node. |
| Number of Participants in Whom a SLN is Detected | Up to 4 weeks | Detection Rate as defined by number of participants in whom a SLN is detected |
| Percent of Hemipelvises Identified With SLN | Up to 4 weeks | Detection rate, as defined by percent of hemipelvises identified with SLN |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Operating Room Time in Minutes | From the time the patient enters the room to the time the patient leaves the room, assessed up to 4 weeks | Total operating room time will be estimated as a mean with 95% confidence interval if the data have an approximately normal distribution. Otherwise, the median and a bootstrapped 95% confidence interval for the median will be reported. Similar summaries will be provided for the console time (robotic)/ operating time. |
| Percent of True Positive SLNs Using Isosulfan Blue and Indocyanine Green Solution | Up to 4 weeks | Percent of true positive SLN identified will be compared between injectants utilized using a two sample test of proportions based on a normal approximation. Comparisons will be performed using two sample tests of proportions based on a normal approximation. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Diagnostic (SLN Mapping, Biopsy, Surgery) Patients undergo SLN mapping using isosulfan blue and/or indocyanine green solution injected directly into the cervix. Following SLN identification and biopsy, patients undergo hysterectomy, bilateral salpingo-oophorectomy, and/or complete pelvic lymphadenectomy. Patients expressing SLN positive for metastasis undergo para-aortic lymphadenectomy. | 46 |
| Total | 46 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 7 |
| Overall Study | Withdrawal by Subject | 5 |
Baseline characteristics
| Characteristic | Diagnostic (SLN Mapping, Biopsy, Surgery) |
|---|---|
| Age, Customized 20-29 years | 1 Participants |
| Age, Customized 30-39 years | 0 Participants |
| Age, Customized 40-49 years | 4 Participants |
| Age, Customized 50-59 years | 7 Participants |
| Age, Customized 60-69 years | 21 Participants |
| Age, Customized 70-79 years | 12 Participants |
| Age, Customized 80-89 years | 1 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 46 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 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 | 0 Participants |
| Race (NIH/OMB) White | 42 Participants |
| Region of Enrollment United States | 46 participants |
| Sex: Female, Male Female | 46 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 58 |
| other Total, other adverse events | 1 / 58 |
| serious Total, serious adverse events | 0 / 58 |
Outcome results
Primary
False Negative Rate as Defined as Proportion of Participants With False Negative Detection
False negative rate = 1-sensitivity or the number of patients with a false negative SLN over the number of patients with a positive SLN plus those with a false negative lymph node
Time frame: Up to 4 weeks
Population: Participants who completed study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Diagnostic (SLN Mapping, Biopsy, Surgery) | False Negative Rate as Defined as Proportion of Participants With False Negative Detection | 0 Proportion of participants |
Primary
Number of Participants in Whom a SLN is Detected
Detection Rate as defined by number of participants in whom a SLN is detected
Time frame: Up to 4 weeks
Population: Participants who completed study
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Diagnostic (SLN Mapping, Biopsy, Surgery) | Number of Participants in Whom a SLN is Detected | 44 Participants |
Primary
Number of Participants With Sentinel Nodes Per Side of Pelvis
Detection rate, as defined as number of participants with a sentinel node found per side of pelvis
Time frame: Up to 4 weeks
Population: Participants who completed study
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Diagnostic (SLN Mapping, Biopsy, Surgery) | Number of Participants With Sentinel Nodes Per Side of Pelvis | Right side of pelvis | 39 participants |
| Diagnostic (SLN Mapping, Biopsy, Surgery) | Number of Participants With Sentinel Nodes Per Side of Pelvis | Left side of pelvis | 36 participants |
Primary
Percent of Hemipelvises Identified With SLN
Detection rate, as defined by percent of hemipelvises identified with SLN
Time frame: Up to 4 weeks
Population: Participants who completed study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Diagnostic (SLN Mapping, Biopsy, Surgery) | Percent of Hemipelvises Identified With SLN | 81.5 Percent of Hemipelvises |
Primary
Percent of True Positive SLN Identified With Surgical Modalities (Open Procedures, Minimally Invasive Procedures, and Single-site Technology)
The percent of true positive SLN identified with surgical modalities using pairwise comparisons for each surgical modality. Comparisons will be performed using two sample tests of proportions based on a normal approximation.
Time frame: Up to 4 weeks
Population: Participants who completed study
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Diagnostic (SLN Mapping, Biopsy, Surgery) | Percent of True Positive SLN Identified With Surgical Modalities (Open Procedures, Minimally Invasive Procedures, and Single-site Technology) | Laparoscopy | 83.3 percentage of true positive SNLs |
| Diagnostic (SLN Mapping, Biopsy, Surgery) | Percent of True Positive SLN Identified With Surgical Modalities (Open Procedures, Minimally Invasive Procedures, and Single-site Technology) | Robot | 86.4 percentage of true positive SNLs |
| Diagnostic (SLN Mapping, Biopsy, Surgery) | Percent of True Positive SLN Identified With Surgical Modalities (Open Procedures, Minimally Invasive Procedures, and Single-site Technology) | Single port | 79.0 percentage of true positive SNLs |
Primary
Sensitivity of Sentential Lymph Node (SLN) Biopsy
Sensitivity estimated as the proportion of true positives among participants with lymph node metastases. Sensitivity Calculation= the number of patients with a positive SLN over those patients with a positive SLN plus those patients with a false negative lymph node.
Time frame: Up to 4 weeks
Population: Participants with with lymph node metastases
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Diagnostic (SLN Mapping, Biopsy, Surgery) | Sensitivity of Sentential Lymph Node (SLN) Biopsy | 100 percent |
Secondary
Percent of True Positive SLNs Using Isosulfan Blue and Indocyanine Green Solution
Percent of true positive SLN identified will be compared between injectants utilized using a two sample test of proportions based on a normal approximation. Comparisons will be performed using two sample tests of proportions based on a normal approximation.
Time frame: Up to 4 weeks
Population: Participants who completed study
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Diagnostic (SLN Mapping, Biopsy, Surgery) | Percent of True Positive SLNs Using Isosulfan Blue and Indocyanine Green Solution | indocyanine green | 86.54 Percentage of true positive SLNs |
| Diagnostic (SLN Mapping, Biopsy, Surgery) | Percent of True Positive SLNs Using Isosulfan Blue and Indocyanine Green Solution | Blue dye | 75 Percentage of true positive SLNs |
Secondary
Total Operating Room Time in Minutes
Total operating room time will be estimated as a mean with 95% confidence interval if the data have an approximately normal distribution. Otherwise, the median and a bootstrapped 95% confidence interval for the median will be reported. Similar summaries will be provided for the console time (robotic)/ operating time.
Time frame: From the time the patient enters the room to the time the patient leaves the room, assessed up to 4 weeks
Population: Participants who completed study
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Diagnostic (SLN Mapping, Biopsy, Surgery) | Total Operating Room Time in Minutes | 158.5 minutes |