Lymph Node Mapping in Patients With Endometrial Cancer

• Sponsor: Ohio State University Comprehensive Cancer Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01818739
• Collaborator: (none)
• Enrollment: 204
• Locations: 2
• Arm: 1
• Actual Duration (Months): 49
• Patients Per Site: 102
• Patients Per Site Per Month: 2.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Endometrial Cancer	Procedure: sentinel lymph node detection; Drug: indocyanine green solution; Drug: isosulfan blue; Procedure: sentinel lymph node biopsy	N/A

Detailed Description

PRIMARY OBJECTIVE:

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

SECONDARY OBJECTIVE:

1. 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 204 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• 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
• Actual Study Start Date: Mar 1, 2013
• Actual Primary Completion Date: Nov 16, 2016
• Actual Study Completion Date: Mar 31, 2017

Arms and Interventions

Arm

Intervention/Treatment

Experimental: sentinel lymph node detection Patients undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue and sentinel lymph node biopsy.

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; Other Names: IC-GREEN ICG solution ; Drug: isosulfan blue; Undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue; Other Names: Lymphazurin N-[4-[4-(diethylamino)phenyl] (2,5-disulfophenyl) Methylene]-2,5-cyclohexadien-1-ylidene]-N-ethylethanaminium hydroxide ; Procedure: sentinel lymph node biopsy; Undergo sentinel lymph node biopsy; Other Names: sentinel node biopsy

Outcome Measures

Primary Outcome Measures

1. Negative Predictive Value of Sentinel Lymph Node Prediction of Metastatic Disease [average of 1-14 days after the procedure when final pathologic evaluation has been completed]

   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.

Secondary Outcome Measures

1. Percentage of Metastatic Cases Found Using Ultra-sectioning and IHC Staining [average of 1-14 days after the procedure when final pathologic evalulation has been completed]

   The percentage of metastatic cases analyzed by H&E will be compared to those of H&E-plus- IHC/ultrastaging using a "z-test".

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Smilow Cancer Hospital at Yale New Haven	New Haven	Connecticut	United States	06520
2	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center	Columbus	Ohio	United States	43210

Sponsors and Collaborators

• Ohio State University Comprehensive Cancer Center

Investigators

• Principal Investigator: Floor Backes, MD, Ohio State University Comprehensive Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• The Jamesline

Publications

• 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.

• Responsible Party: Floor Backes, Principal Investigator, Ohio State University Comprehensive Cancer Center
• ClinicalTrials.gov Identifier: NCT01818739
• Other Study ID Numbers: OSU-12114; NCI-2013-00530
• First Posted: Mar 26, 2013
• Last Update Posted: Jun 22, 2021
• Last Verified: Jun 1, 2021

• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Floor Backes, Principal Investigator, Ohio State University Comprehensive Cancer Center: Endometrial Cancer; Robotic-Assisted Staging
• Additional relevant MeSH terms: Endometrial Neoplasms; Pharmaceutical Solutions

Study Results

Participant Flow

Recruitment Details	The study opened in February 2013 and patients were enrolled between March 2013 and November 2016

Arm/Group Title	Sentinel Lymph Node Detection
Arm/Group Description	Patients undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue and sentinel lymph node biopsy.
Period Title: Overall Study
STARTED	204
COMPLETED	204
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Sentinel Lymph Node Detection
Arm/Group Description	Patients undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue and sentinel lymph node biopsy.
Overall Participants	204
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	60
Sex: Female, Male (Count of Participants)
Female	204 100%
Male	0 0%
Region of Enrollment (participants) [Number]
United States	204 100%
Body Mass Index (BMI) (kg/m^2) [Median (Full Range) ]
Median (Full Range) [kg/m^2]	36.5

Outcome Measures

1. Primary Outcome

Title	Negative Predictive Value of Sentinel Lymph Node Prediction of Metastatic Disease
Description	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.
Time Frame	average of 1-14 days after the procedure when final pathologic evaluation has been completed

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sentinel Lymph Node Detection
Arm/Group Description	Patients with negative SLN who underwent sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue and sentinel lymph node biopsy.
Measure Participants	163
Number (95% Confidence Interval) [percentage of patients]	98.8

2. Secondary Outcome

Title	Percentage of Metastatic Cases Found Using Ultra-sectioning and IHC Staining
Description	The percentage of metastatic cases analyzed by H&E will be compared to those of H&E-plus- IHC/ultrastaging using a "z-test".
Time Frame	average of 1-14 days after the procedure when final pathologic evalulation has been completed

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Sentinel Lymph Node Detection
Arm/Group Description	Patients undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue and sentinel lymph node biopsy.
Measure Participants	204
Number [percentage of patients with positive LN]	17

Adverse Events

Arm/Group Title	Sentinel Lymph Node Detection
Arm/Group Description	Patients undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue and sentinel lymph node biopsy.
All Cause Mortality
	Sentinel Lymph Node Detection
	Affected / at Risk (%)	# Events
Total	0/204 (0%)
Serious Adverse Events
	Sentinel Lymph Node Detection
	Affected / at Risk (%)	# Events
Total	0/204 (0%)
Other (Not Including Serious) Adverse Events
	Sentinel Lymph Node Detection
	Affected / at Risk (%)	# Events
Total	0/204 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.