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

Phase 2

Terminated

• Conditions: Endometrial Cancer
• Interventions: Drug: Lymphoseek; Device: Single Photon Emission Computed Tomography (SPECT); Drug: Indocyanine Green (ICG); Device: Neoprobe Gamma Detection System NPB11L(Model1102)

• Registration Number: NCT04511026
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study First Submitted: 2020-08-07
• Study First Submitted QC: 2020-08-10
• Study First Posted: 2020-08-12
• Study Start: 2021-01-20
• Primary Completion: 2021-06-10
• Study Completion: 2021-06-10
• Results First Submitted: 2023-08-15
• Status Verified: 2023-09
• Results First Submitted QC: 2023-09-18
• Last Update Submitted: 2023-09-18
• Results First Posted: 2023-10-11
• Last Update Posted: 2023-10-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 6

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lymphoseek/SPECT-CT/Indocyanine	Lymphoseek	The subject will receive 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) will be injected into the uterine cervix. Using near-infrared imaging, efferent lymphatic vessels and lymph nodes will be visualized and confirmed by detected radioactivity using a laparoscopic gamma counter. The preoperatively obtained SPECT/CT images will help guide the surgery.
Lymphoseek/SPECT-CT/Indocyanine	Single Photon Emission Computed Tomography (SPECT)	The subject will receive 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) will be injected into the uterine cervix. Using near-infrared imaging, efferent lymphatic vessels and lymph nodes will be visualized and confirmed by detected radioactivity using a laparoscopic gamma counter. The preoperatively obtained SPECT/CT images will help guide the surgery.
Lymphoseek/SPECT-CT/Indocyanine	Indocyanine Green (ICG)	The subject will receive 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) will be injected into the uterine cervix. Using near-infrared imaging, efferent lymphatic vessels and lymph nodes will be visualized and confirmed by detected radioactivity using a laparoscopic gamma counter. The preoperatively obtained SPECT/CT images will help guide the surgery.
Lymphoseek/SPECT-CT/Indocyanine	Neoprobe Gamma Detection System NPB11L(Model1102)	The subject will receive 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) will be injected into the uterine cervix. Using near-infrared imaging, efferent lymphatic vessels and lymph nodes will be visualized and confirmed by detected radioactivity using a laparoscopic gamma counter. The preoperatively obtained SPECT/CT images will help guide the surgery.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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.
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.

Trial Locations

Locations (1)

Stanford University, School of Medicine; 🇺🇸 Stanford, California, United States