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RECRUITING
NCT04719156
PHASE2

Fluorescent Intra-operative Tumor Margin Examination

Sponsor: Kurt Weiss

View on ClinicalTrials.gov

Summary

Tumor margin confirmation is important to confirming appropriate disease excision. Current standard of care is to take select margin samples to pathology for intra-operative readings. However, this is expensive, time consuming, and only assesses the margin contained within the specific sample. In prior work the investigators have determined that indocyanine green (ICG) is highly specific to the tumor bed when injected shortly before surgery. The investigators hypothesize that ICG will be able to accurately identify residual positive tumor margins during sarcoma excision procedures.

Official title: Evaluation of Intraoperative Tumor Margin Identification With Fluorescent Dye Imaging

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

110

Start Date

2021-03-02

Completion Date

2026-12-31

Last Updated

2026-02-20

Healthy Volunteers

No

Conditions

Interventions

DRUG

Indocyanine green solution administered at 2.0mg/kg.

Dosing of ICG to be administered at 2.0mg/kg, two hours prior to surgery.

DEVICE

Stryker SPY-PHI Imaging Device

The SPY-PHI system is used with the ICG dye to provide fluorescence images.

Locations (1)

UPMC-Shadyside Hospital

Pittsburgh, Pennsylvania, United States