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

NCT01886066 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2024-03-15

No results posted yet for this study

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

Interventions

BIOLOGICAL

Indocyanine Green (ICG)

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.

Sponsors & Collaborators

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Sarah Ferguson, MD · The Princess Margaret Cancer Foundation

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2019-06-21
Completion
2021-09-30

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01886066 on ClinicalTrials.gov