RecruitingPhase 1Phase 2NCT04723810

TumorGlow Intraoperative Molecular Imaging (IMI)

A Study to Evaluate the Safety and Efficacy of Indocyanine Green for Intraoperative Molecular Imaging of Solid Tumors (TumorGlow™)

Sponsor

University of Pennsylvania

Enrollment

500 participants

Start Date

Aug 14, 2024

Study Type

INTERVENTIONAL

Conditions

Tumor, Solid

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

Min Age: 18 Years

Inclusion Criteria4

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 Criteria4

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.

Print for Your Doctor

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGIndocyanine Green

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.