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Integrated Imaging System for Breast Cancer

N/A

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Case Comprehensive Cancer CenterLead Sponsor

453 Previous Clinical Trials

31,865 Total Patients Enrolled

55 Trials studying Breast Cancer

4,967 Patients Enrolled for Breast Cancer

Stephanie A Valente, DOPrincipal InvestigatorCleveland Clinic, Case Comprehensive Cancer Center

Media Library

Integrated Imaging Goggles Clinical Trial Eligibility Overview. Trial Name: NCT02802553 — N/A

Breast Cancer Research Study Groups: Integrated Imaging Goggles

Breast Cancer Clinical Trial 2023: Integrated Imaging Goggles Highlights & Side Effects. Trial Name: NCT02802553 — N/A

Integrated Imaging Goggles 2023 Treatment Timeline for Medical Study. Trial Name: NCT02802553 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities to become involved in this research endeavor?

"Clinicaltrials.gov indicates that this clinical trial has been open to recruitment since December 28th 2017, with the listing being most recently updated on July 24th 2021."

Answered by AI

How many participants are being inducted in this clinical trial?

"Yes, according to the medical data hosted on clinicaltrials.gov, this study is actively sourcing participants. It was initially posted in December 2017 and recently updated July of 2023. This trial requires 25 persons from a single site for testing purposes."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2017. "Evaluation of an Integrated Imaging System For In Vivo Detection of Fluorescently Labeled Lesions". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02802553.