Clinical trial NCT04511026: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Endometrial Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2020-08-12
Enrollment: 6
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Number of Participants With Bilateral SLNs
timeFrame: during surgery, an average of 3 hours
Secondary outcomes:
measure: Overall Detection of SLN Detection
timeFrame: during surgery, an average of 3 hours
measure: Number of SLNs Detected by Lymphoseek:
timeFrame: during surgery, an average of 3 hours
measure: Location of SLNs Detected by Lymphoseek:
timeFrame: during surgery, an average of 3 hours
measure: Number of SLNs Detected by Indocyanine Green
timeFrame: during surgery, an average of 3 hours
measure: Location of SLNs Detected by Indocyanine Green
timeFrame: during surgery, an average of 3 hours
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University, School of Medicine
state: California
Study officials:
affiliation: Stanford Universiy
name: Amer K Karam, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.