Indocyanine Green Imaging for Lymphedema in Breast Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: City of Hope Medical Center

Disqualifiers: Active malignancy, Infection, Bleeding tendency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if inserting an IV line and administering fluids affects the lymphatic system in breast cancer patients who might develop lymphedema (arm swelling due to fluid buildup) after surgery. Researchers use a special dye called indocyanine green (ICG) and a camera system to assess blood flow in the arm. This trial is for breast cancer patients who underwent axillary dissection surgery at least a year ago and have difficulty using their other arm for blood draws. As an unphased trial, it offers patients the opportunity to contribute to important research that could enhance post-surgical care for breast cancer patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this diagnostic method is safe for breast cancer patients at risk for lymphedema?

Research has shown that Indocyanine Green (ICG) is safe and commonly used in studies on lymphedema related to breast cancer. It helps doctors assess the lymphatic system, which clears toxins and waste from the body. Studies indicate that most people tolerate ICG well, with few experiencing adverse reactions. Specifically, ICG has proven useful in reducing lymphedema, the swelling from fluid buildup, in breast cancer survivors, highlighting its safety. Although some may worry about side effects, evidence suggests that ICG is a safe option for those considering participation in a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Indocyanine Green (ICG) imaging for lymphedema in breast cancer patients because it offers a new way to visualize lymphatic function and fluid accumulation. Unlike traditional treatments that focus on managing symptoms with compression garments and physical therapy, ICG provides real-time imaging to better assess and monitor the condition's progression. This approach could lead to more personalized and effective management plans by identifying specific areas of lymphatic blockage. Additionally, ICG imaging is non-invasive and can be repeated over time, making it a promising tool for ongoing assessment without the need for more invasive procedures.

What evidence suggests that indocyanine green imaging is effective for assessing lymphedema in breast cancer patients?

Research has shown that indocyanine green (ICG) lymphography can detect lymphatic system issues before swelling, known as edema, becomes visible. In this trial, participants will receive ICG dye and undergo imaging and lymphedema assessments at various intervals. Studies have found that ICG imaging predicts changes in arm size and composition more effectively than clinical exams for those with breast cancer-related lymphedema (BCRL). This capability may help identify issues early and guide preventive measures. Other research indicates that ICG-guided treatments can reduce the risk of developing lymphedema and improve quality of life for high-risk individuals. Overall, these findings suggest that ICG imaging effectively assesses and possibly prevents BCRL. ^{2 4 5 6 7}

Who Is on the Research Team?

Jeff Chang

Principal Investigator

City of Hope Medical Center

Are You a Good Fit for This Trial?

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 have been diagnosed with breast cancer.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Assessment and Treatment

Participants receive ICG dye subcutaneously and fluids IV over one hour, undergo SPY imaging and lymphedema assessment on day 1

1 day

1 visit (in-person)

Follow-up Assessments

Participants receive ICG dye and undergo imaging and lymphedema assessments at 1, 3, 6, and 12 months

12 months

4 visits (in-person)

Long-term Follow-up

Participants are monitored for changes in lymphatic structure and lymphedema severity

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Indocyanine Green

Trial Overview 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.

How Is the Trial Designed?

Group I: Supportive Care (ICG, fluid, SPY, lymphedema assessment) Experimental Treatment 6 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 United States, European Union, China, Japan for the following indications:

Approved in United States as Indocyanine Green for:

• Diagnostic imaging agent for various medical procedures including sentinel lymph node mapping

Approved in European Union as Indocyanine Green for:

• Diagnostic imaging agent for various medical procedures including sentinel lymph node mapping

Approved in China as Indocyanine Green for:

• Diagnostic imaging agent for various medical procedures including sentinel lymph node mapping, liver function testing

Approved in Japan as Indocyanine Green for:

• Diagnostic imaging agent for various medical procedures including sentinel lymph node mapping, liver function testing

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9026904/

Using the Indocyanine Green (ICG) Lymphography to ... Our study aimed to find whether the abnormality of ICG lymphography can predict the occurrence of early lymphedema and then select candidates at high risk of ...

2. nature.com nature.com/articles/s41598-021-00396-2

Indocyanine green lymphangiography is superior to clinical ... This study found that ICG-L staging of BCRL was superior to clinical staging in forecasting BCRL excess arm volume, fat mass, and lean mass.

3. medicaljournalssweden.se medicaljournalssweden.se/JPHS/article/view/44582/51359

Application of indocyanine green lymphography in the ... ICG lymphography could detect lymphatic function disorder even before edema becomes clinically evident. According to the result of ICG ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S152682092400288X

Navigating Lymphedema: The Impact of Indocyanine ... ICG_L-guided interventions effectively reduced lymphedema incidence, improving quality of life in high-risk breast cancer survivors.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06672224

Indocyanine Green Fluoroscopy and SPY Angiography for ... Patients also receive ICG dye and undergo imaging and lymphedema assessments again at 1, 3, 6, and 12 months on study. Official Title. Prospective Analysis of ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06672224

Indocyanine Green Fluoroscopy and SPY Angiography for ... This clinical trial assesses the change in lymphatic structure from placement of an intravenous (IV) line and fluid administration using a diagnostic agent, ...

7. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-019-6192-1

A new indocyanine green fluorescence lymphography ... The aim of this study to summarise initial findings obtained by the new ICG lymphography protocol in breast cancer related lymphoedema.