Concurrent Use Lymphoseek & Indocyanine Green in Sentinel Lymph Node Detection in Endometrial Cancer
NCT04511026 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2023-10-11
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
Interventions
- DRUG
-
Lymphoseek
Radioactive diagnostic agent
- 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.
Sponsors & Collaborators
- lead OTHER
Principal Investigators
-
Amer K Karam, MD · Stanford Universiy
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-01-20
- Primary Completion
- 2021-06-10
- Completion
- 2021-06-10
- FDA Drug
- Yes
- FDA Device
- Yes
Countries
- United States
Study Locations
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