RecruitingPhase 2NCT04719156

Fluorescent Intra-operative Tumor Margin Examination

Evaluation of Intraoperative Tumor Margin Identification With Fluorescent Dye Imaging


Sponsor

Kurt Weiss

Enrollment

110 participants

Start Date

Mar 2, 2021

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a glowing dye called fluorescein can help surgeons more clearly see the edges of bone or soft tissue tumors during surgery, so they can be sure to remove the entire tumor while preserving healthy tissue. **You may be eligible if:** - You are 18 or older - You have a bone or soft tissue tumor that a specialist has recommended for surgical removal - Your tumor has been confirmed by biopsy and has a known risk of coming back after surgery - You have not had prior surgery on this tumor **You may NOT be eligible if:** - You are under 18 - You are pregnant or breastfeeding - You have a history of severe allergic reaction to contrast dyes or fluorescein - You have kidney failure or are on dialysis - Your tumor is one that rarely comes back (like a non-recurrent osteochondroma) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGIndocyanine green solution administered at 2.0mg/kg.

Dosing of ICG to be administered at 2.0mg/kg, two hours prior to surgery.

DEVICEStryker SPY-PHI Imaging Device

The SPY-PHI system is used with the ICG dye to provide fluorescence images.


Locations(1)

UPMC-Shadyside Hospital

Pittsburgh, Pennsylvania, United States

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NCT04719156


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