TumorGlow Intraoperative Molecular Imaging (IMI)

University of Pennsylvania

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Tumor, Solid

Treatments: Drug: Indocyanine Green

Study type: Interventional

Funder types: Other

Identifiers

NCT04723810

844554

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Cohort 1

Experimental group

Description:

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.

Treatment:

Drug: Indocyanine Green

Cohort 2

Experimental group

Description:

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.

Treatment:

Drug: Indocyanine Green