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

Stanford University

Status and phase: Terminated; Phase 2

Conditions: Endometrial Cancer

Treatments: Drug: Lymphoseek; Device: Neoprobe Gamma Detection System NPB11L(Model1102); Drug: Indocyanine Green (ICG); Device: Single Photon Emission Computed Tomography (SPECT)

Study type: Interventional

Funder types: Other

Identifiers

NCT04511026

IRB-53978 (Other Identifier)

GYNEND0006 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 6 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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6 participants in 1 patient group

Lymphoseek/SPECT-CT/Indocyanine

Experimental group

Description:

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.

Treatment:

Device: Single Photon Emission Computed Tomography (SPECT)

Drug: Indocyanine Green (ICG)

Device: Neoprobe Gamma Detection System NPB11L(Model1102)

Drug: Lymphoseek