← Back to Search

Fluorescent Dye

Indocyanine Green Imaging for Lymphedema in Breast Cancer

N/A

Waitlist Available

Led By Jeff Chang

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

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

Must have

No clinical evidence of lymphedema by MD Anderson grading system and normal SOZO values compared to contralateral arm

Be older than 18 years old

Must not have

Women of childbearing potential who are pregnant or nursing

Patients with active malignancy (i.e., currently undergoing treatment), infection, or bleeding tendency

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to study the effect of placing an IV line and giving fluids to breast cancer patients at risk for lymphedema. The researchers will use a diagnostic dye called indocyanine green (

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

Potential side effects may include allergic reactions to the indocyanine green dye or discomfort from the IV placement. The SPY angiography procedure itself is non-invasive but might cause some anxiety or discomfort during imaging.

Eligibility Criteria

Inclusion Criteria

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

Select...

I don't have swelling in my arm compared to the other, as per my doctor's assessment.

Exclusion Criteria

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

Select...

I am not pregnant or nursing.

Select...

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

Select...

I have been diagnosed with lymphedema.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 12 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Percentage of patients with worsening lymphedema in the affected arm

Secondary study objectives

Change in arm circumference measurements

Change in lymphedema severity based on SOZO Digital Health Platform scale

Change in patient self-reported outcomes scores

+1 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: 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Indocyanine Green

2008

Completed Phase 2

~1050

0 / 4Eligibility criteria met