50 Participants Needed

Indocyanine Green Imaging for Lymphedema in Breast Cancer

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: City of Hope Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

Trial Summary

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 data supports the effectiveness of the treatment Indocyanine Green (ICG) for lymphedema in breast cancer?

Indocyanine Green (ICG) imaging has been shown to help identify and evaluate lymphatic vessel issues in lymphedema, which can guide surgical treatment and management. This suggests it may be useful in assessing and managing lymphedema in breast cancer patients.12345

Is Indocyanine Green (ICG) safe for use in humans?

The research articles provided do not contain specific safety data for Indocyanine Green (ICG) in humans, but they do not report any safety concerns either. ICG is commonly used in medical imaging, suggesting it is generally considered safe for such purposes.14678

How is the treatment Indocyanine Green (ICG) unique for lymphedema in breast cancer?

Indocyanine Green (ICG) is unique because it is used as a dye to visualize and evaluate lymphatic function, helping to identify areas of lymphatic dysfunction in lymphedema. This imaging technique allows for a detailed assessment of lymphatic channels, which can guide treatment decisions and staging of the condition, unlike traditional treatments that do not provide such visual insights.12349

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

JC

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 have been diagnosed with breast cancer.
See 3 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.

Timeline

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

Treatment Details

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.
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 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

Find a Clinic Near You

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+

References

The Pittsburgh Trunk Lymphedema Staging System (PTLSS) - a validated staging system for the description of breast cancer-associated trunk lymphedema. [2022]
A phase III, multicenter, single-arm study to assess the utility of indocyanine green fluorescent lymphography in the treatment of secondary lymphedema. [2022]
[Application progress of indocyanine green angiography in lymphedema]. [2022]
Characteristic indocyanine green lymphography findings in lower extremity lymphedema: the generation of a novel lymphedema severity staging system using dermal backflow patterns. [2022]
Application of combined preoperative indocyanine green lymphography and ultrasonography for low-pressure vein localization in secondary lymphedema surgery for breast cancer. [2023]
A Novel Way of Standardization of ICG Lymphangiography Reporting. [2021]
Using the Indocyanine Green (ICG) Lymphography to Screen Breast Cancer Patients at High Risk for Lymphedema. [2023]
Relationship Between the Circumference Difference and Findings of Indocyanine Green Lymphography in Breast Cancer-Related Lymphedema. [2023]
Indocyanine Green Lymphography Findings in Primary Leg Lymphedema. [2016]
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