Evaluation of Intraoperative Tumor Margin Identification With Fluorescent Dye Imaging
Kurt Weiss
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.
Description
Experimental Design: 1. A physician investigator will obtain consent during the pre-operative appointment. Study team members may assist with the discussion. 2. Upon arrival to the pre-operative area 2 hours prior to surgery, the participant will be injected with 2.0 mg/kg ICG (Indocyanine Green Dye) as per standard protocol: during regular pre-operative work-up, during which a standard of care IV is inserted. The PI or resident physician will administer the injection. 3. The participant will undergo the tumor removal surgery as planned pre-operatively. To assess the accuracy and precisio…
Eligibility
- Age range
- 18–100 years
- Sex
- All
- Healthy volunteers
- No
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 th…
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.
Location
- UPMC-Shadyside HospitalPittsburgh, Pennsylvania