TumorGlow Intraoperative Molecular Imaging (IMI)

Tumor, Solid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04723810
• Other study ID #: 844554
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: October 31, 2024
• Est. completion date: January 14, 2026

Study information

• Verified date: January 2024
• Source: University of Pennsylvania
• Contact: Azra Din
• Phone: 215-615-7980
• Email: azra.din[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: January 14, 2026
• Est. primary completion date: January 14, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Tumor, Solid

Intervention

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

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cohort 1: Determine the safety of indocyanine green (all tumor types combined)	Type, frequency, severity, and attribution of AEs/SAEs (all tumor types combined).	Up to 5 days
Primary	Cohort 1: Identify optimal dosing of indocyanine green before surgery, and camera combination (tumor type-specific)	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.	Up to 5 days
Primary	Cohort 1: Identify optimal timing of indocyanine green before surgery, and camera combination (tumor type-specific)	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.	Up to 5 days
Primary	Cohort 2: Determine the sensitivity and specificity of indocyanine green (tumor type-specific)	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)	Up to 5 days
Primary	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)	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.	Up to 5 days
Secondary	Cohort 1: Provide preliminary estimates of the sensitivity and specificity of indocyanine green (or TumorGlow) for identifying cancerous areas (tumor type-specific)	Nodule/lesion-level and subject-level sensitivity and specificity of indocyanine green (or TumorGlow) for identifying cancerous areas (tumor type-specific).	Up to 5 days
Secondary	Cohort 1: Provide preliminary estimate of the efficacy of indocyanine green for locating additional cancers and missed surgical margins as measured by CSE rate (tumor type-specific)	Clinically Significant Event (CSE) rate (tumor type-specific).	Up to 5 days
Secondary	Cohort 2: Confirm the safety of indocyanine green (all tumor types combined)	Type, frequency, severity, and attribution of AEs/SAEs (all tumor types combined).	Up to 5 days