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RECRUITING
NCT04723810
PHASE1/PHASE2

TumorGlow Intraoperative Molecular Imaging (IMI)

Sponsor: University of Pennsylvania

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

500

Start Date

2024-08-14

Completion Date

2027-01-14

Last Updated

2026-03-09

Healthy Volunteers

No

Conditions

Interventions

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.

Locations (1)

University of Pennsylvania

Philadelphia, Pennsylvania, United States