Clinical trial · Interventional
Concurrent Use Lymphoseek & Indocyanine Green in Sentinel Lymph Node Detection in Endometrial Cancer
Concurrent Use of Lymphoseek and Indocyanine Green for Sentinel Lymph Node Detection in Endometrial Cancer - a Prospective Study
NCT04511026CI-TRIAL-00070404terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Efficacy
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Indocyanine Green (ICG) | Drug | — | UNRESOLVED |
| Lymphoseek | Drug | — | UNRESOLVED |
| Neoprobe Gamma Detection System NPB11L(Model1102) | Device | — | UNRESOLVED |
| Single Photon Emission Computed Tomography (SPECT) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Lymphoseek/SPECT-CT/Indocyanine
- 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.
- interventionNames
- Drug: Lymphoseek
- Device: Single Photon Emission Computed Tomography (SPECT)
- Drug: Indocyanine Green (ICG)
- Device: Neoprobe Gamma Detection System NPB11L(Model1102)
Primary outcomes (1)
- measure
- Number of Participants With Bilateral SLNs
- timeFrame
- during surgery, an average of 3 hours
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTReddy 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