Lymph Node Mapping in Patients With Endometrial Cancer

Endometrial Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01818739
• Other study ID #: OSU-12114
• Secondary ID: NCI-2013-00530
• Status: Completed
• Phase: N/A
• Start date: March 2013
• Est. completion date: March 31, 2017

Study information

• Verified date: March 2023
• Source: Ohio State University Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This clinical trial studies lymph node mapping in patients with endometrial cancer. Lymph node mapping may allow for limited removal of lymph nodes in as part of endometrial cancer staging and treatment.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 204
• Est. completion date: March 31, 2017
• Est. primary completion date: November 16, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms

Intervention

Procedure:
• sentinel lymph node detection
Undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue

Drug:
• indocyanine green solution
Undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue
• isosulfan blue
Undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue

Procedure:
• sentinel lymph node biopsy
Undergo sentinel lymph node biopsy

Locations

Country	Name	City	State
United States	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center	Columbus	Ohio
United States	Smilow Cancer Hospital at Yale New Haven	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

Backes FJ, Cohen D, Salani R, Cohn DE, O'Malley DM, Fanning E, Suarez AA, Fowler JM. Prospective clinical trial of robotic sentinel lymph node assessment with isosulfane blue (ISB) and indocyanine green (ICG) in endometrial cancer and the impact of ultrastaging (NCT01818739). Gynecol Oncol. 2019 Jun;153(3):496-499. doi: 10.1016/j.ygyno.2019.03.252. Epub 2019 Apr 4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Negative Predictive Value of Sentinel Lymph Node Prediction of Metastatic Disease	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.	average of 1-14 days after the procedure when final pathologic evaluation has been completed
Secondary	Percentage of Metastatic Cases Found Using Ultra-sectioning and IHC Staining	The percentage of metastatic cases analyzed by H&E will be compared to those of H&E-plus- IHC/ultrastaging using a "z-test".	average of 1-14 days after the procedure when final pathologic evalulation has been completed

External Links

•   The Jamesline