Accuracy of Sentinel Lymph Node Biopsy in Nodal Staging of High Risk Endometrial Cancer

NCT01886066 | Completed

• 1 other identifier: 12-0257-C
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 2

Brief Summary

The standard of care for women with high risk endometrial cancer is the removal of all visible lymph nodes in the pelvis and lower abdomen to identify if disease has spread to these areas. It is estimated that no more than 25% of all women with presumed early stage high risk endometrial cancer will have positive lymph nodes however currently the majority of women are subjected to extensive resection of all pelvic lymph and or para-aortic lymph nodes and its associated morbidities. The objective of this study is to determine if intraoperative sentinel lymph node (SLN) mapping will improve the assessment of regional lymph nodes and enhance the detection of lymph nodes with metastatic disease in endometrial cancer. This would benefit the majority of women with early stage high risk endometrial cancer and would prevent the associated complications of pelvic lymph node dissection.

Conditions

Endometrial Cancer; Sentinel Lymph Node; Indocyanine Green

Outcome Measures

Primary Outcomes (1)

• Performance Analysis

  Performance analyses of SLN mapping will be performed. In particular, sensitivity, specificity, and predictive accuracy of mapping and detection of sentinel lymph nodes with metastatic disease will be calculated using the pathology results of the surgical intervention as the Standard of Reference. Performance analyses will be evaluated at both the lesion and patient level. Generalized estimating equations will be used to adjust for correlations of repeated measures within patients. Raw performance estimates will be reported with adjusted 95% confidence intervals.

  Year 3

Study Arms (1)

Indocyanine Green

EXPERIMENTAL

All patients on study will have ICG injection for SLN mapping

Biological: Indocyanine Green (ICG)

Interventions

Indocyanine Green (ICG) BIOLOGICAL

ICG (Indocyanine Green) will be used as a fluorescent agent to identify sentinel lymph nodes intraoperatively. One 25 mg vial of ICG will be reconstituted in 10 mL of aqueous solvent (2.5 mg/mL). The solution will be injected at the 3 and 9 o'clock positions of the cervical stroma. 0.5 mL is injected superficially (submucosa) and 0.5 mL is injected deep (\~8mm) in the cervical stroma for a total injection volume of 2 mL.

Indocyanine Green

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women with endometrial cancer with high risk histologic subtypes including grade 3 endometrioid, carcinosarcoma, serous, clear cell, undifferentiated adenocarcinoma, and and any mixed high risk histology.
• Clinical stage 1 disease- no evidence of metastatic disease beyond the uterus by physical exam or preoperative imaging if performed.
• Patients who have signed an approved informed consent.
• Patients who will undergo surgery that includes a hysterectomy and bilateral pelvic and inframesenteric para-aortic lymphadenectomy via laparoscopy or robotic-assisted.

You may not qualify if:

• Women with grade 1 or 2 endometrioid adenocarcinoma
• Patients with evidence of metastatic disease on preoperative imaging.
• Patients with evidence of intraperitoneal metastatic disease intraoperatively (patients with suspicious retroperitoneal lymph nodes intraoperatively will still be included).
• Patients with known allergy to iodine compounds
• Pregnant patient.
• Patients with previous retroperitoneal surgery.
• Patients with previous history of pelvic/abdominal radiation.
• Patients with recurrent endometrial cancer.
• Any patient treated with neoadjuvant chemotherapy and/or radiation.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (2)

Sunnybrook Health Sciences Center

Toronto, Ontario, M4N3M5, Canada

Location

University Health Network - Princess Margaret Hospital

Toronto, Ontario, M5T 2M9, Canada

Location

Related Publications (1)

• Marchocki Z, Cusimano MC, Vicus D, Pulman K, Rouzbahman M, Mirkovic J, Cesari M, Maganti M, Zia A, Ene G, Ferguson SE. Diagnostic accuracy of frozen section and patterns of nodal spread in high grade endometrial cancer: A secondary outcome of the SENTOR prospective cohort study. Gynecol Oncol. 2023 Jun;173:41-48. doi: 10.1016/j.ygyno.2023.04.004. Epub 2023 Apr 18.

  PMID: 37075495 DERIVED

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Sarah Ferguson, MD

  The Princess Margaret Cancer Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an Investigator-Initiated Prospective Trial (not a clinical trial, as ICG not a novel drug that is being used as intervention).

Study Record Dates

• First Submitted: June 20, 2013
• First Posted: June 25, 2013
• Study Start: March 1, 2012
• Primary Completion: June 21, 2019
• Study Completion: September 1, 2021
• Last Updated: March 15, 2024

Record last verified: 2024-03

Locations

CA (2)