NCT04723810 TumorGlow Intraoperative Molecular Imaging (IMI)
| NCT ID | NCT04723810 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | University of Pennsylvania |
| Condition | Tumor, Solid |
| Study Type | INTERVENTIONAL |
| Enrollment | 500 participants |
| Start Date | 2024-08-14 |
| Primary Completion | 2027-01-14 |
Trial Parameters
Eligibility Fast-Check
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Brief 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
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.