Lymph Node Mapping in Patients With Newly Diagnosed Endometrial Cancer Undergoing Surgery

Not Applicable

Terminated

Conditions: Stage I Endometrial Carcinoma
Stage II Endometrial Carcinoma
Stage III Endometrial Carcinoma
Stage IV Endometrial Carcinoma

Interventions: Procedure: lymph node mapping
Procedure: sentinel lymph node biopsy
Drug: isosulfan blue
Drug: indocyanine green solution
Procedure: therapeutic conventional surgery
Procedure: lymphadenectomy

Registration Number: NCT01939028

Lead Sponsor: Case Comprehensive Cancer Center

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: Female

Target Recruitment: 58

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic (SLN mapping, biopsy, surgery)	lymph node mapping	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.
Diagnostic (SLN mapping, biopsy, surgery)	sentinel lymph node biopsy	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.
Diagnostic (SLN mapping, biopsy, surgery)	therapeutic conventional 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.
Diagnostic (SLN mapping, biopsy, surgery)	lymphadenectomy	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.
Diagnostic (SLN mapping, biopsy, surgery)	indocyanine green solution	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.
Diagnostic (SLN mapping, biopsy, surgery)	isosulfan blue	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.

Primary Outcome Measures

Name	Time	Method
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
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
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.

Secondary Outcome Measures

Name	Time	Method
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.
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.