TumorGlow Intraoperative Molecular Imaging (IMI) for Solid Tumors
This study is testing a drug called indocyanine green to help surgeons better see solid tumors during surgery. It's for adults (18 years or older) who have a solid tumor or diseased tissue that doctors believe can be removed by surgery. The main goals are to find out if indocyanine green is safe, and to determine the best dose and timing for giving the drug before surgery, as well as the best camera to use. This will help doctors evaluate how well image-guided surgery works using indocyanine green. The study is currently recruiting up to 500 participants.
- Study design
- This is a Phase 1/2 interventional study, meaning it's an early-stage trial looking at safety and initial effectiveness. It plans to enroll up to 500 participants.
- What's involved
- You would receive a single dose of indocyanine green intravenously (into a vein) up to 5 days before your scheduled surgery. The exact dose and timing will depend on your tumor type.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety will be monitored for up to 5 days after receiving the indocyanine green.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
TumorGlow Intraoperative Molecular Imaging (IMI)
At a glance
Conditions
NCT04723810
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
University of Pennsylvania
Philadelphia, Pennsylvaniastudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Inclusion
Exclusion
What this trial measures
- Cohort 1: Determine the safety of indocyanine green (all tumor types combined)Up to 5 days
Type, frequency, severity, and attribution of AEs/SAEs (all tumor types combined).
- Cohort 1: Identify optimal dosing of indocyanine green before surgery, and camera combination (tumor type-specific)Up to 5 days
Dosing of indocyanine green, and camera combination with the highest tumor-to-background ratio (TBR) (tumor type-specific). The minimum acceptable TBR value is 2.
- Cohort 1: Identify optimal timing of indocyanine green before surgery, and camera combination (tumor type-specific)Up to 5 days
Timing of indocyanine green, and camera combination with the highest tumor-to-background ratio (TBR) (tumor type-specific). The minimum acceptable TBR value is 2.
- Cohort 2: Determine the sensitivity and specificity of indocyanine green (tumor type-specific)Up to 5 days
Nodule/lesion-level and subject-level sensitivity and specificity of TumorGlow (tumor type-specific). * Sensitivity of indocyanine green = TP/(TP+FN) = (# that fluoresce and are cancer)/(# that are cancer) * Specificity of indocyanine green = TN/(TN+FP) = (# that not cancer and do not fluoresce)/(# that are not cancer)
- Cohort 2: Confirm the efficacy of indocyanine green used with Near Infrared (NIR) fluorescent imaging as measured by Clinically Significant Event (CSE) rate (tumor type-specific)Up to 5 days
Clinically Significant Event (CSE) rate (tumor type-specific). A CSE includes any of the following event: * One or more primary nodule (cancerous or non-cancerous) not detected under normal light and/or palpation but is detected by imaging, * One or more cancerous synchronous lesion not detected under normal light and/or palpation but is detected by imaging, * The identification of a cancer positive margin that fluoresces within (less than or equal to) 5 mm of the surgical margin.