University of Pennsylvania
This is a Phase 1/2 study in patients presenting with any solid tumor and/or diseased tissue even benign nodules presumed to be resectable and at risk for recurrence on pre-operative assessment who are considered to be good surgical candidates to evaluate the safety and efficacy of the image-guided surgery using indocyanine green for intramolecular imaging of solid tumors.
Inclusion Criteria: * Adult patients 18 years of age or older. * Patients presenting with any solid tumor and/or diseased tissue even benign nodules presumed to be resectable and at risk for recurrence on pre-operative assessment. * Good operative candidate as determined by the treating physician and/or multidisciplinary team. * Subject capable of giving informed consent. Exclusion Criteria: * Subject unable to participate in the consent process. * Vulnerable population including pregnant women, prisoners, and children. * History of uncontrolled hypertension (e.g., history of an ER admissio…
The investigational drug is indocyanine green, single dose between 1-5 mg/kg diluted into sterile water for intravenous (IV) injection up to 5 days prior to resection surgery. The actual dose and timing from dose to imaging will be determined based on tumor type.
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