Prospective Study on ICG Lymphoscintigraphy Changes Before and After Radiotherapy in Breast Cancer Patients

The goal of this observational study is to learn how the lymphatic system changes before and after radiotherapy in female patients with breast cancer. The study aims to understand early lymphatic changes that may lead to breast-cancer-related lymphedema (BCRL) and to help identify patients who might benefit from early preventive rehabilitation. The main questions it aims to answer are: How does lymphatic flow and vessel function change after radiotherapy, as measured by indocyanine green (ICG) lymphography? Can early imaging changes on ICG lymphography predict later swelling or lymphedema symptoms in the arm? There is no comparison or treatment group, since all participants will receive radiotherapy as part of their standard breast cancer care. Participants will: Undergo ICG lymphography before radiotherapy and again within 4-6 weeks after completing radiotherapy Receive a small injection of ICG dye under the skin and have near-infrared imaging to visualize lymphatic flow Complete follow-up assessments (for some participants) at 3, 6, or 12 months to monitor long-term lymphatic changes Continue their usual standard medical and rehabilitation care throughout the study This study will include 40 female participants, aged 18 years or older, who have been diagnosed with stage I-III breast cancer and are scheduled for postoperative radiotherapy. Participants with a history of lymphedema, prior radiotherapy, severe organ disease, or known ICG/iodine allergy will not be included. The information collected will include imaging findings from ICG lymphography, arm circumference and volume measurements, and patient-reported outcomes on arm discomfort or swelling. These data will help researchers identify early imaging biomarkers of radiation-induced lymphatic dysfunction. The study does not involve any experimental treatment or random assignment. All procedures are routine diagnostic or rehabilitation methods that are already approved for clinical use. The ICG test uses a very small amount of dye and is considered safe, with allergic reactions being rare. The findings of this study may provide new insights into how radiotherapy affects the lymphatic system and may contribute to developing personalized strategies to prevent or minimize lymphedema after breast cancer treatment.

NCT Number	NCT07297927
Lead Sponsor	Inah Kim
Conditions	Breast Neoplasms, Lymphedema Due to Radiation
Enrollment	40 participants
Start Date	2025-11-05
Primary Completion	2026-02-28 (estimated)
Study Completion	2028-10-18 (estimated)
Updated on ClinicalTrials.gov	2025-12-22