Actively Recruiting

Phase 2
Age: 18Years - 100Years
All Genders
NCT04719156

Fluorescent Intra-operative Tumor Margin Examination

Led by Kurt Weiss · Updated on 2026-02-20

110

Participants Needed

1

Research Sites

304 weeks

Total Duration

On this page

Sponsors

K

Kurt Weiss

Lead Sponsor

S

Stryker Nordic

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Fluorescent Intra-operative Tumor Margin Examination

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients above the age of 18 with a primary musculoskeletal tumor indicated for surgical excision by a fellowship trained orthopaedic oncologist
  • Surgical consent obtained prior to research consent
  • Biopsy-confirmed primary soft tissue or bone tumor not previously excised with known risk of local or remote recurrence
Not Eligible

You will not qualify if you...

  • Patients below the age of 18
  • Pregnancy or breastfeeding
  • History of anaphylactic reaction to contrast media or fluorescein allergy
  • Prior surgery local to the mass being excised
  • Non- or minimally-recurrent masses such as osteochondroma
  • Dialysis, renal failure, or uremia

AI-Screening

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Trial Site Locations

Total: 1 location

1

UPMC-Shadyside Hospital

Pittsburgh, Pennsylvania, United States, 15213

Actively Recruiting

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Research Team

B

Beata Krawczyk, krawbx@upmc.edu

CONTACT

K

Kurt Weiss, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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