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

Study results available
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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

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

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04511026 on ClinicalTrials.gov