NCT04719156 · Kurt Weiss
Fluorescent Intra-operative Tumor Margin Examination
(ICGTM)
What this study is about
Tumor margin confirmation is important to confirming appropriate disease excision. Current the usual treatment 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.
View original scientific description
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.
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.
Primary outcome measures
Tumor recurrence as predicted by the surgeon vs. identified with SPY.
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Pittsburgh, Pennsylvania
Collaborators
Stryker Nordic
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
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How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 20, 2026 · Source of record for eligibility and locations