UPCC 28920 A Study to Evaluate the Safety and Efficacy of Image Guided Surgery using Indocyanine Green for Intramolecular Imaging of Solid Tumors Compared to Standard of Care, (TumorGlow™)
Study on Surgery for Tumors Using Special Imaging
Brief description of study
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.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Tumor, Solid
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Age: 18 years or above
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Gender: All
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.
This study investigates the use of image-guided surgery with indocyanine green for imaging solid tumors. The purpose is to evaluate the safety and effectiveness of this method compared to the standard surgical care. Patients involved are those with solid tumors or diseased tissue, including benign nodules, which are considered resectable and at risk for recurrence.
Participants will undergo surgery where indocyanine green, a dye, is used to help visualize the tumors during the operation. This procedure aims to improve the precision of tumor removal by providing better imaging of the tumor margins.
- Who can participate: Adults aged 18 or older with any solid tumor or resectable diseased tissue, who are good surgical candidates and can provide informed consent, are eligible. Key exclusions include pregnant women, prisoners, children, those with uncontrolled hypertension, or iodide allergies.
- Study details: Participants will have surgery where a dye called indocyanine green is used to help see the tumors better. This is done to improve the surgeon's ability to remove the tumor accurately.
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