Evaluation of an Integrated Imaging System For In Vivo Detection of Fluorescently Labeled Lesions

Running, not enrolling · Not applicable

Conditions studied: Invasive Breast Cancer

In brief

This is a pilot study to test and characterize the ability of the Smart Goggles system to detect fluorescently labeled sentinel lymph nodes (SLNs). Specifically, this study will test the sensitivity and specificity of the Smart Goggles to detect indocyanine green (ICG) accumulation in sentinel lymph nodes of breast cancer patients after peritumoral injection of ICG (Cardio-GreenTM), under standard-of-care application conditions.

Key facts

Study ID

NCT02802553

Run by

Case Comprehensive Cancer Center

People needed

2

Starts

2017-12-28

Expected to finish

2024-12-01

Last updated by the study team

2024-08-27

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Subjects with at least 1 lesion of tumor of the breast
• Subjects must have the ability to understand and the willingness to sign a written informed consent document.

You may not qualify if…

• Subjects who have been treated with radiation therapy on the chest.
• Has had previous sentinel lymph node biopsy
• Has a known hypersensitivity to ICG, methylene blue and 99mTc-colloid.

Where it is running

• Cleveland Clinic, Case Comprehensive Cancer Center — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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