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

• Sponsor: Stanford University (Other)
• Overall Status: Suspended
• CT.gov ID: NCT04511026
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 23.4
• Patients Per Site Per Month: 0.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endometrial Cancer	Drug: Lymphoseek; Device: Single Photon Emission Computed Tomography (SPECT); Drug: Indocyanine Green (ICG); Device: Neoprobe Gamma Detection System NPB11L(Model1102)	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Concurrent Use of Lymphoseek and Indocyanine Green for Sentinel Lymph Node Detection in Endometrial Cancer - a Prospective Study
• Actual Study Start Date: Jan 20, 2021
• Anticipated Primary Completion Date: Jan 1, 2023
• Anticipated Study Completion Date: Jan 1, 2023

Arms and Interventions

Arm

Intervention/Treatment

Experimental: 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.

Drug: Lymphoseek; Radioactive diagnostic agent; Other Names: technetium Tc 99m tilmanocept ; Device: Single Photon Emission Computed Tomography (SPECT); Imaging test; Drug: Indocyanine Green (ICG); Cyanine dye used in medical diagnostics manufactured by Akorn Inc.; Device: Neoprobe Gamma Detection System NPB11L(Model1102); Neoprobe Gamma Detection System NPB11L(Model1102) made by Devicor Medical Products, Inc.; Other Names: Laparoscopic handheld gamma counter

Outcome Measures

Primary Outcome Measures

1. Bilateral sentinel lymph node (SLN) detection rate [Time of surgery]

   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. Bilateral sentinel lymph node (SLN) detection rate, which will be calculated as the number of patients with bilateral SLN detection divided by the total number of patients.

Secondary Outcome Measures

1. Overall detection of SLN detection [Time of surgery]

   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'.

2. Location of SLNs detected by Lymphoseek: [Time of surgery]

   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.

3. Number of SLNs detected by Lymphoseek: [Time of surgery]

   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.

4. Number of SLNs detected by Indocyanine Green [Time of surgery]

   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.

5. Location of SLNs detected by Indocyanine Green [Time of surgery]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University, School of Medicine	Stanford	California	United States	94304

Sponsors and Collaborators

• Stanford University

Investigators

• Principal Investigator: Amer K Karam, MD, Stanford Universiy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Stanford University
• ClinicalTrials.gov Identifier: NCT04511026
• Other Study ID Numbers: IRB-53978; GYNEND0006; IRB-53978
• First Posted: Aug 12, 2020
• Last Update Posted: Jun 15, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Endometrial Neoplasms

Study Results

No Results Posted as of Jun 15, 2022