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

NCT ID: NCT04511026

Last Updated: 2023-10-11

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-20
• Study Completion Date: 2021-06-10

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.

Conditions

Endometrial Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Lymphoseek/SPECT-CT/Indocyanine

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.

Group Type: EXPERIMENTAL

Lymphoseek

Intervention Type: DRUG

Radioactive diagnostic agent

Single Photon Emission Computed Tomography (SPECT)

Intervention Type: DEVICE

Imaging test

Indocyanine Green (ICG)

Intervention Type: DRUG

Cyanine dye used in medical diagnostics manufactured by Akorn Inc.

Neoprobe Gamma Detection System NPB11L(Model1102)

Intervention Type: DEVICE

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

Interventions

Lymphoseek

Radioactive diagnostic agent

Intervention Type: DRUG

Single Photon Emission Computed Tomography (SPECT)

Imaging test

Intervention Type: DEVICE

Indocyanine Green (ICG)

Cyanine dye used in medical diagnostics manufactured by Akorn Inc.

Intervention Type: DRUG

Neoprobe Gamma Detection System NPB11L(Model1102)

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

Intervention Type: DEVICE

Other Intervention Names

technetium Tc 99m tilmanocept; Laparoscopic handheld gamma counter

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Amer Karam

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amer K Karam, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford Universiy

Locations

Stanford University, School of Medicine

Stanford, California, United States

Countries

United States

References

Reddy RA, Moon AS, Chow S, Heilbroner L, Howitt B, Diver E, Dorigo O, Litkouhi B, Renz M, Karam A. Technetium Tc 99m tilmanocept fails to detect sentinel lymph nodes in endometrial cancer. Gynecol Oncol Rep. 2022 Jul 30;43:101054. doi: 10.1016/j.gore.2022.101054. eCollection 2022 Oct.

Reference Type: RESULT

PMID: 35958955 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

GYNEND0006

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-53978

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-53978

Identifier Type: -

Identifier Source: org_study_id