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Fluorescent Intra-operative Tumor Margin Examination

NCT04719156 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2026-02-20

No results posted yet for this study

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.

Conditions

  • Sarcoma

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.

Sponsors & Collaborators

  • Stryker Nordic

    collaborator INDUSTRY

  • Kurt Weiss

    lead OTHER

Principal Investigators

  • Kurt E Weiss · University of Pittsburgh

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-02
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT04719156 on ClinicalTrials.gov