Sentinel Lymph Node Mapping for Endometrial Cancer
Overview
- Phase
- Not Applicable
- Intervention
- lymph node mapping
- Conditions
- Stage I Endometrial Carcinoma
- Sponsor
- Case Comprehensive Cancer Center
- Enrollment
- 58
- Locations
- 1
- Primary Endpoint
- Sensitivity of Sentential Lymph Node (SLN) Biopsy
- Status
- Terminated
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
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.
Intervention: lymph node mapping
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.
Intervention: sentinel lymph node biopsy
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.
Intervention: isosulfan blue
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.
Intervention: indocyanine green solution
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.
Intervention: therapeutic conventional surgery
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.
Intervention: lymphadenectomy
Outcomes
Primary Outcomes
Sensitivity of Sentential Lymph Node (SLN) Biopsy
Time Frame: 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
Time Frame: Up to 4 weeks
Detection Rate as defined by number of participants in whom a SLN is detected
Percent of Hemipelvises Identified With SLN
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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 Outcomes
- Percent of True Positive SLNs Using Isosulfan Blue and Indocyanine Green Solution(Up to 4 weeks)
- 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)