Concurrent Use Lymphoseek & Indocyanine Green in Sentinel Lymph Node Detection in Endometrial Cancer

Phase 2TerminatedNCT04511026

Stanford University6 enrolled

Overview

The goal of this study is to (i) improve detection of sentinel nodes and (ii) reduce additional surgical dissection that is needed in case a sentinel lymph node cannot be detected.

Primary Objective: To determine the detection rate of bilateral sentinel lymph nodes with the concurrent use of Lymphoseek and Indocyanine Green. Secondary Objective: (1) To determine the overall detection rate of sentinel lymph nodes with concurrent use of Lymphoseek and Indocyanine Green (2) To determine location and number of Lymphoseek-positive sentinel lymph nodes preoperatively by single-photon emission computed tomography (SPECT/CT imaging) and intraoperatively by a laparoscopic handheld gamma detection device and near- infrared fluorescent imaging (3) To determine the concordance of Lymphoseek-positive sentinel lymph nodes with intraoperatively detected Indocyanine Green-positive sentinel lymph nodes.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Endometrial Cancer

Interventions

LymphoseekDRUG

Radioactive diagnostic agent

Single Photon Emission Computed Tomography (SPECT)DEVICE

Imaging test

Indocyanine Green (ICG)DRUG

Cyanine dye used in medical diagnostics manufactured by Akorn Inc.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * The patient has histological diagnosis of cancer of the endometrium of any histology or grade. * The patient should have received no prior treatment for her endometrial cancer. * The patient has clinically uterine confined disease. * The patient is a candidate for minimal invasive surgery, with sentinel lymph node assessment with IC-GREEN planned as part of standard of care. * The patient has an Eastern Cooperative Group (ECOG) performance status of 0-2. * If age less than or equal to 55 years, the patient has a negative pregnancy test within 72 hours before administration of Lymphoseek, has been surgically sterilized, or has been postmenopausal for at least 1 year. * The patient has provided written informed consent. * The patient is at least 18 years of age at the time of consent Exclusion Criteria: * The patient has clinical or radiological evidence of metastatic disease. * The patient has a history of a prior loop electrosurgical excision procedure (LEEP) or cone procedure performed on her cervix. * The patient has participated in another investigational drug study within 30 days of scheduled surgery. * The patient has an iodine allergy. * The patient is pregnant or lactating.

Locations (1)

Stanford University, School of Medicine

Stanford, California, United States

Outcomes

Primary Outcomes

Number of Participants With Bilateral SLNs

A sentinel lymph node will be defined as being detected if it is detected on the pre-operative SPECT/CT imaging scan or intraoperatively using near-infrared imaging or the handheld gamma detection device.

Time frame: during surgery, an average of 3 hours

Secondary Outcomes

Overall Detection of SLN Detection

For each subject, an assessment will be made of whether there was overall sentinel node detection. A sentinel lymph node will be defined as being detected if it is detected on the pre-operative SPECT/CT imaging scan or intraoperatively using near-infrared imaging or the handheld gamma detection device. If at least one SLN is detected (on any side), then this outcome will be considered a 'Yes'.

Time frame: during surgery, an average of 3 hours

Number of SLNs Detected by Lymphoseek:

The number of sentinel lymph nodes detected by Lymphoseek will be assessed. A sentinel lymph node will be defined as being detected by Lymphoseek if it is detected using the pre-operative SPECT/CT imaging scan and/or intraoperatively using the gamma detection device.

Time frame: during surgery, an average of 3 hours

Location of SLNs Detected by Lymphoseek:

The location and number of sentinel lymph nodes detected by Lymphoseek will be assessed. A sentinel lymph node will be defined as being detected by Lymphoseek if it is detected using the pre-operative SPECT/CT imaging scan and/or intraoperatively using the gamma detection device.

Time frame: during surgery, an average of 3 hours

Number of SLNs Detected by Indocyanine Green

Number of SLNs detected by Indocyanine Green: The location and number of sentinel lymph nodes detected by Indocyanine Green will be assessed. A sentinel lymph node will be defined as being detected by Indocyanine Green if it is detected intraoperatively using near-infrared imaging only and not by the gamma detection device.

Data from ClinicalTrials.gov

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