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

Sentinel Lymph Node Mapping for Endometrial Cancer

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.

Study Overview

• Status: Terminated
• Conditions: Stage IV Endometrial Carcinoma; Stage III Endometrial Carcinoma; Stage II Endometrial Carcinoma; Stage I Endometrial Carcinoma
• Intervention / Treatment: Procedure: lymph node mapping; Procedure: sentinel lymph node biopsy; Drug: isosulfan blue; Drug: indocyanine green solution; Procedure: therapeutic conventional surgery; Procedure: lymphadenectomy

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.

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: 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.

Procedure: lymph node mapping; Undergo lymph node mapping using isosulfan blue and/or indocyanine green solution; Procedure: sentinel lymph node biopsy; Undergo SLN biopsy; Other Names: sentinel node biopsy; Drug: isosulfan blue; Undergo lymph node mapping using isosulfan blue and/or indocyanine green solution; Other Names: Lymphazurin; N-[4-[4-(diethylamino)phenyl] (2,5-disulfophenyl) Methylene]-2,5-cyclohexadien-1-ylidene]-N-ethylethanaminium hydroxide; Drug: indocyanine green solution; Undergo lymph node mapping using isosulfan blue and/or indocyanine green solution; Other Names: IC-GREEN; ICG solution; Procedure: therapeutic conventional surgery; Undergo hysterectomy, bilateral salpingo-oophorectomy and/or complete pelvic lymphadenectomy; Procedure: lymphadenectomy; Undergo para-aortic lymphadenectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 4 weeks
Number of Participants in Whom a SLN is Detected	Detection Rate as defined by number of participants in whom a SLN is detected	Up to 4 weeks
Percent of Hemipelvises Identified With SLN	Detection rate, as defined by percent of hemipelvises identified with SLN	Up to 4 weeks
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	Up to 4 weeks
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	Up to 4 weeks
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.	Up to 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to 4 weeks
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.	From the time the patient enters the room to the time the patient leaves the room, assessed up to 4 weeks

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Investigators: Principal Investigator: Chad Michener, MD, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (ACTUAL): October 1, 2016
• Study Completion (ACTUAL): October 1, 2016

Study Registration Dates

• First Submitted: July 10, 2013
• First Submitted That Met QC Criteria: September 5, 2013
• First Posted (ESTIMATE): September 11, 2013

Study Record Updates

• Last Update Posted (ACTUAL): August 27, 2020
• Last Update Submitted That Met QC Criteria: August 26, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Carcinoma; Endometrial Neoplasms; Pharmaceutical Solutions
• Other Study ID Numbers: CASE9813; NCI-2013-01309 (REGISTRY: CTRP (Clinical Trial Reporting Program))