NCT04723810PHASE1, PHASE2Recruiting
TumorGlow Intraoperative Molecular Imaging (IMI)
University of Pennsylvania
Start Date
8/14/2024
Completion Date
1/14/2027
Summary
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.
Eligibility Criteria
Age Range: 18 years to No maximum
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 admission for hypertensive crisis or ≥ 3 blood pressure medications)
* Patients with a self-reported history of iodide allergies.
Interventions
DRUG
Indocyanine Green
Conditions
Tumor, Solid
Locations
University of Pennsylvania
Philadelphia, Pennsylvania 19104
United States