TumorGlow Intraoperative Molecular Imaging (IMI)

NCT04723810 | Recruiting Phase 1 FDA Drug

• 1 other identifier: 844554
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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 Outcomes (3)

• Cohort 1: Provide preliminary estimates of the sensitivity and specificity of indocyanine green (or TumorGlow) for identifying cancerous areas (tumor type-specific)

  Up to 5 days

• 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)

  Up to 5 days

• Cohort 2: Confirm the safety of indocyanine green (all tumor types combined)

  Up to 5 days

Study Arms (2)

Cohort 1

EXPERIMENTAL

Patients scheduled to undergo surgical resection for the following cancers (known or suspected) that the safety and dosing/timing of indocyanine green has not been fully studied will be enrolled: glioma, breast cancer, colon cancer, rectal cancer, head and neck cancer, pulmonary metastasectomy (colorectal mets), thymoma, ovarian cancer, prostate cancer, renal cell carcinoma, thyroid cancer, parathyroid adenoma, mesothelioma, esophageal cancer, pancreas cancer, stomach cancer.

Drug: Indocyanine Green

Cohort 2

EXPERIMENTAL

Patients scheduled to undergo surgical resection for the following cancers (known or suspected) that the safety and dosing/timing of indocyanine green has been fully studied will be enrolled: non-small cell lung cancer, metastatic sarcoma to the lung, brain meningioma.

Drug: Indocyanine Green

Interventions

Indocyanine Green DRUG

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.

Cohort 1; Cohort 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

Indocyanine Green

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Azra Din

CONTACT

215-615-7980; azra.din@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2021
• First Posted: January 26, 2021
• Study Start: August 14, 2024
• Primary Completion (Estimated): January 14, 2027
• Study Completion (Estimated): January 14, 2027
• Last Updated: March 9, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)