NCT04723810

TumorGlow Intraoperative Molecular Imaging (IMI)

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 500 (estimated)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tumor, Solid

Interventions

Type	Name	Description
DRUG	Indocyanine 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.

Timeline

• Start date: 2024-08-14
• Primary completion: 2027-01-14
• Completion: 2027-01-14
• First posted: 2021-01-26
• Last updated: 2026-03-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study