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

Concurrent Use of Lymphoseek and Indocyanine Green for Sentinel Lymph Node Detection in Endometrial Cancer - a Prospective Study

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04511026

Enrollment

Registered

2020-08-12

Start date

2021-01-20

Completion date

2021-06-10

Last updated

2023-10-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Cancer

Brief summary

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.

Detailed description

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.

Interventions

DRUGLymphoseek

Radioactive diagnostic agent

DEVICESingle Photon Emission Computed Tomography (SPECT)

Imaging test

DRUGIndocyanine Green (ICG)

Cyanine dye used in medical diagnostics manufactured by Akorn Inc.

DEVICENeoprobe Gamma Detection System NPB11L(Model1102)

Neoprobe Gamma Detection System NPB11L(Model1102) made by Devicor Medical Products, Inc.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With Bilateral SLNs	during surgery, an average of 3 hours	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.

Secondary

Measure	Time frame	Description
Overall Detection of SLN Detection	during surgery, an average of 3 hours	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'.
Number of SLNs Detected by Lymphoseek:	during surgery, an average of 3 hours	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.
Location of SLNs Detected by Lymphoseek:	during surgery, an average of 3 hours	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.
Number of SLNs Detected by Indocyanine Green	during surgery, an average of 3 hours	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.
Location of SLNs Detected by Indocyanine Green	during surgery, an average of 3 hours	Location 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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Lymphoseek/SPECT-CT/Indocyanine Participants received f 0.5 mL each Lymphoseek into the uterine cervix prior to surgery and subsequent SPECT/CT imaging preoperatively. Intraoperatively, following anesthesia induction, Indocyanine Green (0.5 mL) was injected into the uterine cervix. Using near-infrared imaging, efferent lymphatic vessels and lymph nodes were visualized and confirmed by detected radioactivity using a laparoscopic gamma counter. The preoperatively obtained SPECT/CT images helped guide the surgery.	6
Total	6

Arm

Count

Lymphoseek/SPECT-CT/Indocyanine

Participants received f 0.5 mL each Lymphoseek into the uterine cervix prior to surgery and subsequent SPECT/CT imaging preoperatively. Intraoperatively, following anesthesia induction, Indocyanine Green (0.5 mL) was injected into the uterine cervix. Using near-infrared imaging, efferent lymphatic vessels and lymph nodes were visualized and confirmed by detected radioactivity using a laparoscopic gamma counter. The preoperatively obtained SPECT/CT images helped guide the surgery.

Total

Baseline characteristics

Characteristic	Lymphoseek/SPECT-CT/Indocyanine
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	2 Participants
Age, Categorical Between 18 and 65 years	4 Participants
Histology Endometrioid Grade 1	3 Participants
Histology Endometrioid Grade 2	3 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	0 Participants
Race (NIH/OMB) Black or African American	0 Participants
Race (NIH/OMB) More than one race	0 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	5 Participants
Race (NIH/OMB) White	1 Participants
Region of Enrollment United States	6 Participants
Sex: Female, Male Female	6 Participants
Sex: Female, Male Male	0 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 6
other Total, other adverse events	0 / 6
serious Total, serious adverse events	0 / 6

Outcome results

Primary

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.