Recruiting
Phase 1
Phase 2

TumorGlow

Sponsor:

University of Pennsylvania

Code:

NCT04723810

Conditions

Tumor, Solid

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Indocyanine Green

Study Details

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

Study ID

NCT04723810

Start date

Aug 14, 2024

Status verified date

Mar, 2026

Completion date

Jan 14, 2027

Anticipated

Primary completion date

Jan 14, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

500 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cohort 1

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.

experimental: Cohort 2

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.

Interventions

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.

Primary outcome measure

  • Cohort 1: Determine the safety of indocyanine green (all tumor types combined) [ Time Frame: Up to 5 days ]
  • Cohort 1: Identify optimal dosing of indocyanine green before surgery, and camera combination (tumor type-specific) [ Time Frame: Up to 5 days ]
  • Cohort 1: Identify optimal timing of indocyanine green before surgery, and camera combination (tumor type-specific) [ Time Frame: Up to 5 days ]
  • Cohort 2: Determine the sensitivity and specificity of indocyanine green (tumor type-specific) [ Time Frame: 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) [ Time Frame: Up to 5 days ]

Central Contacts and Locations

Central contacts

Azra Din

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

Locations

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Azra Din, MPH

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

azra.din@pennmedicine.upenn.edu

More Information

Sponsor

University of Pennsylvania

Last update posted

Mar 9, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-03-09.