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SPY AGENT GREEN (indocyanine green) · 1 trial · 1 indication
The proportion of tumors declared "completely removed" by the surgeon that recur locally will be compared those with SPY-identified residual disease.
| Arm | Type | Description |
|---|---|---|
| ICG use followed by SPY-PHI imaging. | OTHER | Participants will be injected with 2.0mg/kg of ICG dye to access tumor margin using Stryker SPY imaging technology. |
| Name | Type | Description |
|---|---|---|
| Indocyanine green solution administered at 2.0mg/kg. | DRUG | Dosing of ICG to be administered at 2.0mg/kg, two hours prior to surgery. |
| Stryker SPY-PHI Imaging Device | DEVICE | The SPY-PHI system is used with the ICG dye to provide fluorescence images. |
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 ...
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SPY AGENT GREEN is an indocyanine green formulation being studied in sarcoma to help surgeons examine tumor margins during surgery. It is given intravenously at 2.0 mg/kg before or during an operation so that fluorescent imaging can highlight tissue around the tumor. It is investigational and is not an approved cancer treatment.
SPY AGENT GREEN is developed by Stryker Corporation, which trades on the New York Stock Exchange under the ticker SYK. Stryker is the sponsor of the clinical program evaluating the agent in sarcoma surgery.
SPY AGENT GREEN is in Phase 2 clinical development. It is an investigational agent and has not been approved by the FDA for sarcoma or any other indication. The Phase 2 study is currently recruiting participants.
SPY AGENT GREEN is being evaluated in the Phase 2 trial NCT04719156, titled Fluorescent Intra-operative Tumor Margin Examination. The study is recruiting an estimated 110 adults aged 18 and older with sarcoma at sites in the United States. It is an uncontrolled, non-randomized, open-label study.
SPY AGENT GREEN is an indocyanine green solution, and it is also referred to as indocyanine green administered at 2.0 mg/kg. Indocyanine green is the active agent, while SPY AGENT GREEN is the specific formulation and dosing used in the sarcoma surgical imaging study.