Indocyanine Green Imaging for Lymphedema in Breast Cancer
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.12345
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.24567
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Initial Assessment and Treatment
Participants receive ICG dye subcutaneously and fluids IV over one hour, undergo SPY imaging and lymphedema assessment on day 1
Follow-up Assessments
Participants receive ICG dye and undergo imaging and lymphedema assessments at 1, 3, 6, and 12 months
Long-term Follow-up
Participants are monitored for changes in lymphatic structure and lymphedema severity
What Are the Treatments Tested in This Trial?
Interventions
- Indocyanine Green
Indocyanine Green is already approved in United States, European Union, China, Japan for the following indications:
- Diagnostic imaging agent for various medical procedures including sentinel lymph node mapping
- Diagnostic imaging agent for various medical procedures including sentinel lymph node mapping
- Diagnostic imaging agent for various medical procedures including sentinel lymph node mapping, liver function testing
- 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
National Cancer Institute (NCI)
Collaborator