← Back to Search

Integrated Imaging System for Breast Cancer

N/A

Waitlist Available

Led By Stephanie A Valente, DO

Research Sponsored by Case Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects with at least 1 lesion of tumor of the breast

Be older than 18 years old

Must not have

Subjects who have had previous sentinel lymph node biopsy

Subjects who have been treated with radiation therapy on the chest

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at the end of the procedure, about 50 minutes

Awards & highlights

No Placebo-Only Group

Summary

This trial tests how effective a new device called Smart Goggles is at finding sentinel lymph nodes in breast cancer patients. It tests the accuracy and precision of the goggles.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Potential side effects may include allergic reactions to the dyes used (like Cardio-Green), which could manifest as skin rashes, itching, or more severe hypersensitivity reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have at least one breast tumor lesion.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had a sentinel lymph node biopsy before.

Select...

I have received radiation therapy on my chest.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at the end of the procedure, about 50 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at the end of the procedure, about 50 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and at the end of the procedure, about 50 minutes for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Binary response of the number of participants in which the Smart Goggles identifies the same Sentinel Lymph Nodes (SLN) within each participant as those identified by the gamma probe and blue dyes gold standard.

Secondary study objectives

Binary response of the number of participants in which the Smart Goggles identifies the same Sentinel Lymph Nodes (SLN) within each participant as those identified by the SPY/Quest/PDE imaging systems.

Fluorescence intensity

Number of removed lymph nodes with cancer cells

+5 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 3Eligibility criteria met