Fluorescent Intra-operative Tumor Margin Examination

Recruiting now · Phase 2

Conditions studied: Sarcoma

In brief

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.

Key facts

Study ID

NCT04719156

Run by

Kurt Weiss

People needed

110

Starts

2021-03-02

Expected to finish

2026-12-31

Last updated by the study team

2026-02-20

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• Patients below the age of 18
• Pregnancy, breast feeding
• Patients with a history of anaphylactic reaction to contrast media or fluorescein allergy
• Prior surgery local to the mass being excised
• Non- or minimally-recurrent masses (i.e. osteochondroma)
• Dialysis, renal failure, uremia

Where it is running

• UPMC-Shadyside Hospital — Pittsburgh, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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