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

NCT04511026 | Terminated Phase 2 Results DMC FDA Drug FDA Device

• 2 other identifiers: IRB-53978GYNEND0006
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometrial Cancer

Outcome Measures

Primary Outcomes (1)

• 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.

  during surgery, an average of 3 hours

Secondary Outcomes (5)

• Overall Detection of SLN Detection

  during surgery, an average of 3 hours

• Number of SLNs Detected by Lymphoseek:

  during surgery, an average of 3 hours

• Location of SLNs Detected by Lymphoseek:

  during surgery, an average of 3 hours

• Number of SLNs Detected by Indocyanine Green

  during surgery, an average of 3 hours

• Location of SLNs Detected by Indocyanine Green

  during surgery, an average of 3 hours

Study Arms (1)

Lymphoseek/SPECT-CT/Indocyanine

EXPERIMENTAL

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.

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

Interventions

Lymphoseek DRUG

Radioactive diagnostic agent

Also known as: technetium Tc 99m tilmanocept

Lymphoseek/SPECT-CT/Indocyanine

Single Photon Emission Computed Tomography (SPECT) DEVICE

Imaging test

Lymphoseek/SPECT-CT/Indocyanine

Indocyanine Green (ICG) DRUG

Cyanine dye used in medical diagnostics manufactured by Akorn Inc.

Lymphoseek/SPECT-CT/Indocyanine

Neoprobe Gamma Detection System NPB11L(Model1102) DEVICE

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

Also known as: Laparoscopic handheld gamma counter

Lymphoseek/SPECT-CT/Indocyanine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University, School of Medicine

Stanford, California, 94304, United States

Location

Related Publications (1)

• 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.

  PMID: 35958955 RESULT

MeSH Terms

Conditions

Endometrial Neoplasms

Interventions

technetium-diethylenetriaminepentaacetic acid-mannosyl-dextran; Tomography, Emission-Computed, Single-Photon; Indocyanine Green

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

This study did not meet its planned enrollment and did not achieve statistical power.

Results Point of Contact

• Title: Amer Karam, MD
• Organization: Stanford University

amkaram@stanford.edu

650-498-6004

Study Officials

• Amer K Karam, MD

  Stanford Universiy

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: August 7, 2020
• First Posted: August 12, 2020
• Study Start: January 20, 2021
• Primary Completion: June 10, 2021
• Study Completion: June 10, 2021
• Last Updated: October 11, 2023
• Results First Posted: October 11, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)