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Fluorescent Intra-operative Tumor Margin Examination

RecruitingPhase 2Ages 18 Years - 100 YearsAllKurt Weiss
NCT04719156 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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
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What it tests

  • Indocyanine green solution administered at 2.0mg/kg.
  • Stryker SPY-PHI Imaging Device
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Where

1 site
UPMC-Shadyside Hospital
Pittsburgh, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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