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Fluorescent Imaging for Sarcoma Surgery

This study is testing a new way to help surgeons remove sarcoma tumors more completely. It uses a special dye called Indocyanine green (ICG) and a device called Stryker SPY-PHI. Before surgery, you would receive the ICG dye. During surgery, the SPY-PHI device helps the surgeon see if any tumor cells are left behind after the main tumor is removed. The goal is to see if this method can accurately predict if the tumor will come back, compared to the surgeon's usual assessment. You may be able to join if you are over 18, have a primary musculoskeletal tumor that needs surgery, and have not had it removed before. The study plans to enroll 110 participants.

Study design
This is an interventional study involving 110 participants. It is designed to compare the surgeon's prediction of tumor recurrence with the results from the SPY-PHI imaging.
What's involved
You would receive an injection of Indocyanine green (ICG) dye two hours before your planned tumor removal surgery. During surgery, the Stryker SPY-PHI device will be used to take images.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome of tumor recurrence prediction is measured during surgery for tumor removal.

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NCT04719156

Fluorescent Intra-operative Tumor Margin Examination

Recruiting
PHASE2Ages 18+InterventionalDiagnostic
Kurt Weiss
~110 participants
Updated 2026-02-20 on ClinicalTrials.gov
What's tested:Indocyanine green solution administered at 2.0mg/kg.Stryker SPY-PHI Imaging Device

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Tumor recurrence as predicted by the surgeon vs. identified with SPY.
Measured over During surgery for tumor removal

Conditions

Sarcoma

Explore related trials

Sarcoma

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • Kurt E Weiss · PRINCIPAL_INVESTIGATOR · University of Pittsburgh

Who to contact

Beata Krawczyk, [email protected]
[email protected]
412-401-3000
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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

What this trial measures

  • Tumor recurrence as predicted by the surgeon vs. identified with SPY.During surgery for tumor removal

    The proportion of tumors declared "completely removed" by the surgeon that recur locally will be compared those with SPY-identified residual disease.