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ICG-Enabled Mapping of Ovarian Sentinel Lymph Nodes: A Feasibility Study

NCT04051502 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-12-17

No results posted yet for this study

Summary

The purpose of this study is to find out how well ovarian sentinel lymph nodes (SLNs) can be identified with indocyanine green (ICG) dye during risk-reducing ovarian surgery.

Conditions

Interventions

DRUG

Method 1: Indocyanine green dye

Injection 4 mL of ICG dye directly into the fallopian tube (1 or more places is acceptable) only to the side where the adnexal mass is located

DRUG

Method 2: Indocyanine green dye

1mL of ICG injected at each of the four sites: only to the side where the adnexal mass is located * Dorsal side of the IP ligament * Ventral side of the IP ligament * Dorsal side of the utero-ovarian ligament * Ventral side of the utero-ovarian ligament

DRUG

Method 3: Indocyanine green dye

Injection of 2mL of ICG dye into the IP ligament pedicle after the adnexal mass has been removed. Only to the side where the adnexal mass is located

DRUG

Method 3: Indocyanine green dye

Injection of 2mL of ICG dye into the IP ligament pedicle before the adnexal mass is removed.

Sponsors & Collaborators

Principal Investigators

  • Ginger Gardner, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-08-05
Primary Completion
2025-12-08
Completion
2025-12-08

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

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 NCT04051502 on ClinicalTrials.gov