Indocyanine Green Imaging for Lymphedema in Breast Cancer
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?
Is Indocyanine Green (ICG) safe for use in humans?
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
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
Exclusion Criteria
Timeline
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
Treatment Details
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