Trial Outcomes & Findings for Lymph Node Mapping in Patients With Endometrial Cancer (NCT NCT01818739)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

204 participants

Primary outcome timeframe

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

Results posted on

2023-03-22

Participant Flow

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

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	204
Overall Study COMPLETED	204
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lymph Node Mapping in Patients With Endometrial Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sentinel Lymph Node Detection n=204 Participants Patients undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue and sentinel lymph node biopsy.
Age, Continuous	60 years n=5 Participants
Sex: Female, Male Female	204 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	204 participants n=5 Participants
Body Mass Index (BMI)	36.5 kg/m^2 n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Sentinel Lymph Node Detection n=163 Participants 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.
Negative Predictive Value of Sentinel Lymph Node Prediction of Metastatic Disease	98.8 percentage of patients Interval 95.5 to 99.7

SECONDARY outcome

Timeframe: 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".

Outcome measures

Outcome measures
Measure	Sentinel Lymph Node Detection n=204 Participants 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.
Percentage of Metastatic Cases Found Using Ultra-sectioning and IHC Staining	17 percentage of patients with positive LN

Adverse Events

Sentinel Lymph Node Detection

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Floor Backes, MD

The Ohio State University Comprehensive Cancer Center

Phone: 614-730-6968

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place