NCT04051502

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Ovarian Cancer
• Adnexal Mass

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-08-05
• Primary completion: 2025-12-08
• Completion: 2025-12-08
• First posted: 2019-08-09
• Last updated: 2025-12-17

Locations

7 sites across 1 country: United States