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Detection of Sentinel Lymph Nodes in Patients With Endometrial Cancer Undergoing Robotic-Assisted Staging: Comparison of Isosulfan Blue and Indocyanine Green Dyes With Fluorescence Imaging


N/A
18 Years
85 Years
Open (Enrolling)
Female
Endometrial Cancer

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Trial Information

Detection of Sentinel Lymph Nodes in Patients With Endometrial Cancer Undergoing Robotic-Assisted Staging: Comparison of Isosulfan Blue and Indocyanine Green Dyes With Fluorescence Imaging


PRIMARY OBJECTIVE:

I. To estimate the negative predictive value of pelvic sentinel lymph node (SLN) in
endometrial cancer to predict nodal metastasis.

SECONDARY OBJECTIVE:

II. To examine the ability of sentinel lymph nodes to increase the detection of metastatic
disease through ultra-sectioning and immuno-histochemical (IHC) staining by comparing IHC
results and standard hematoxylin and eosin (H&E) results.

OUTLINE:

Patients undergo sentinel lymph node detection using fluorescence imaging with indocyanine
green solution and isosulfan blue and sentinel lymph node biopsy and detection of sentinel
lymph nodes is noted in the within 30 minutes of injection of the dye, followed by full
pelvic lymph node dissection and aortic lymph node dissection as indicated, and standard
hysterectomy and salpingo-oophorectomy.

After completion of study treatment, patients are followed up every 3 months for 2 years,
every 6 months for 3 years for a total of 5 years according to the standard surveillance
guidelines for endometrial cancer.


Inclusion Criteria:



- The patient must be willing and able to provide informed consent

- The patient is willing and able to comply with the study protocol

- The patient has endometrial cancer and is scheduled for robotic hysterectomy and
lymphadenectomy

- The patient agrees to follow-up examinations out to 5-years post-treatment

Exclusion Criteria:

- The patient is not a candidate for robotic assisted hysterectomy and lymphadenectomy

- The patient has known or suspected allergies to iodine, indocyanine green (ICG) or
isosulfan blue (ISB)

- The patient has hepatic dysfunction confirmed by bilirubin > 2 x normal (based on
reference values from the laboratory used by the patient)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

negative predictive value of sentinel lymph node prediction of metastatic disease

Outcome Description:

The detection rate is calculated as the number of patients with bilaterally detected pelvis SLN divided by a total number of patients who undergo labeling and SLN mapping. Sensitivity estimated as the proportion of true positives among the patients with pelvic lymph node metastases. NPV is found by dividing the number of true negatives by the number of all patients without pelvic lymph node metastases. Exact 95% confidence intervals (CIs) for the proportions will be calculated, and subgroup analysis is done with a two-sided chi-square test or Fischer's exact test.

Outcome Time Frame:

average of 1-14 days after the procedure when final pathologic evaluation has been completed

Safety Issue:

No

Principal Investigator

Floor Backes, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

OSU-12114

NCT ID:

NCT01818739

Start Date:

February 2013

Completion Date:

Related Keywords:

  • Endometrial Cancer
  • Endometrial Cancer
  • Robotic-Assisted Staging
  • Endometrial Neoplasms
  • Sarcoma, Endometrial Stromal
  • Adenoma

Name

Location

Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical CenterColumbus, Ohio  43210-1240