Back to resultsConcurrent Use Lymphoseek & Indocyanine Green in Sentinel Lymph Node Detection in Endometrial Cancer
Primary Purpose
Endometrial Cancer
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lymphoseek
Single Photon Emission Computed Tomography (SPECT)
Indocyanine Green (ICG)
Neoprobe Gamma Detection System NPB11L(Model1102)
Sponsored by
About this trial
This is an interventional diagnostic trial for Endometrial Cancer
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.
Sites / Locations
- Stanford University, School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lymphoseek/SPECT-CT/Indocyanine
Arm 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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Overall Detection of SLN Detection
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:
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 Lymphoseek:
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
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.
Location of SLNs Detected by Indocyanine Green
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04511026
Brief Title
Concurrent Use Lymphoseek & Indocyanine Green in Sentinel Lymph Node Detection in Endometrial Cancer
Official Title
Concurrent Use of Lymphoseek and Indocyanine Green for Sentinel Lymph Node Detection in Endometrial Cancer - a Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Terminated
Why Stopped
Efficacy
Study Start Date
January 20, 2021 (Actual)
Primary Completion Date
June 10, 2021 (Actual)
Study Completion Date
June 10, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lymphoseek/SPECT-CT/Indocyanine
Arm Type
Experimental
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Lymphoseek
Other Intervention Name(s)
technetium Tc 99m tilmanocept
Intervention Description
Radioactive diagnostic agent
Intervention Type
Device
Intervention Name(s)
Single Photon Emission Computed Tomography (SPECT)
Intervention Description
Imaging test
Intervention Type
Drug
Intervention Name(s)
Indocyanine Green (ICG)
Intervention Description
Cyanine dye used in medical diagnostics manufactured by Akorn Inc.
Intervention Type
Device
Intervention Name(s)
Neoprobe Gamma Detection System NPB11L(Model1102)
Other Intervention Name(s)
Laparoscopic handheld gamma counter
Intervention Description
Neoprobe Gamma Detection System NPB11L(Model1102) made by Devicor Medical Products, Inc.
Primary Outcome Measure Information:
Title
Number of Participants With Bilateral SLNs
Description
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.
Time Frame
during surgery, an average of 3 hours
Secondary Outcome Measure Information:
Title
Overall Detection of SLN Detection
Description
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'.
Time Frame
during surgery, an average of 3 hours
Title
Number of SLNs Detected by Lymphoseek:
Description
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.
Time Frame
during surgery, an average of 3 hours
Title
Location of SLNs Detected by Lymphoseek:
Description
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.
Time Frame
during surgery, an average of 3 hours
Title
Number of SLNs Detected by Indocyanine Green
Description
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.
Time Frame
during surgery, an average of 3 hours
Title
Location of SLNs Detected by Indocyanine Green
Description
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.
Time Frame
during surgery, an average of 3 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amer K Karam, MD
Organizational Affiliation
Stanford Universiy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University, School of Medicine
City
Stanford
State/Province
California
ZIP/Postal Code
94304
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35958955
Citation
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.
Results Reference
result
Learn more about this trial
Concurrent Use Lymphoseek & Indocyanine Green in Sentinel Lymph Node Detection in Endometrial Cancer
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