Integrated Imaging System for Breast Cancer

Recruiting in Palo Alto (17 mi)

Overseen byStephanie A Valente, DO

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Case Comprehensive Cancer Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for breast cancer patients with at least one tumor lesion who can understand and sign consent. It's not for those allergic to ICG, methylene blue, or 99mTc-colloid, nor for patients previously treated with chest radiation or who've had a sentinel lymph node biopsy.

Inclusion Criteria

I have at least one breast tumor lesion.

Subjects must have the ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria

Subjects with a known hypersensitivity to ICG, methylene blue, and 99mTc-colloid.

I have had a sentinel lymph node biopsy before.

I have received radiation therapy on my chest.

Treatment Details

Interventions

Smart Goggle (Imaging System)

Trial OverviewThe study tests the Smart Goggles system's ability to detect fluorescently labeled sentinel lymph nodes in breast cancer patients using various imaging systems and dyes like Cardio-Green under standard conditions.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Integrated Imaging GogglesExperimental Treatment7 Interventions

Cardio-GreenTM (indocyanine green) peritumorally injected to breast tumor with 1 cycle. Viewed by Smart Googles and compare lesions detected by commercial FDA approved near infrared camera device (SPY Elite/Quest/PDE) in addition to those detected by gamma probe and blue dyes.