Indocyanine Green Imaging for Lymphedema in Breast Cancer

Recruiting in Palo Alto (17 mi)

Overseen byJeff Chang

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: City of Hope Medical Center

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

This clinical trial assesses the change in lymphatic structure from placement of an intravenous (IV) line and fluid administration using a diagnostic agent, indocyanine green (ICG), with SPY (Trademark) angiography in breast cancer patients at risk for breast cancer-related lymphedema (BCRL). Patients that are diagnosed with breast cancer with lymph node involvement often undergo treatment that includes surgery to remove the axillary nodes and radiation. Unfortunately, this procedure increases the incidence of BCRL in the surgical arm, as well as other problems including heaviness of the arm, fibrotic skin changes, and an increase in infection risk. Because of these symptoms, venipuncture (blood draw) is often avoided in these arms. Researchers want to show that placement of an IV line and fluid administration in patients at risk for BCRL will indeed not alter the lymphatic structure of the arm and will not change the incidence of BCRL by administering indocyanine green (ICG) dye to patients and assessing their arm lymphatics. ICG is a fluorescent dye that is able to be visualized by the SPY angiography imaging system as it travels through the lymphatic system, allowing researchers to assess how well blood flows throughout the body. Receiving ICG and undergoing SPY angiography may be effective in showing that placement of an IV and fluid administration in breast cancer patients at risk for BCRL will not alter the lymphatic structure of their arm and will not change the incidence of BCRL.

Research Team

Jeff Chang

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

This trial is for adults over 18 with breast cancer who've had full axillary dissection at least a year ago and need an IV but have issues using the other arm. They must consent to surveys, measurements, imaging, and record reviews. It's not for pregnant/nursing women, those with active cancer treatments, infections or bleeding tendencies, or diagnosed lymphedema.

Inclusion Criteria

Documented written informed consent of the participant

Willingness to complete Lymphedema Life Impact Scale (LLIS) survey, allow measurement of arm circumference, bioimpedance, and ICG imaging in real time, and permit medical record/clinical laboratory result review

I am 18 years old or older.

See 4 more

Exclusion Criteria

I am not pregnant or nursing.

I am currently being treated for cancer, have an infection, or tend to bleed easily.

I have been diagnosed with lymphedema.

Treatment Details

Interventions

Indocyanine Green (Fluorescent Dye)

Trial OverviewThe study tests if IV lines and fluid therapy affect lymphatic structure in patients at risk of BCRL by using indocyanine green dye with SPY angiography imaging. The goal is to ensure these procedures don't worsen lymphedema risks in the affected arm.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Supportive Care (ICG, fluid, SPY, lymphedema assessment)Experimental Treatment6 Interventions

Patients receive ICG dye SC and receive fluids IV over one hour and undergo SPY imaging and lymphedema assessment on day 1. Patients also receive ICG dye and undergo imaging and lymphedema assessments again at 1, 3, 6, and 12 months on study.

Indocyanine Green is already approved in China, Japan for the following indications: