Actively Recruiting
Prospective Study on ICG Lymphoscintigraphy Changes Before and After Radiotherapy in Breast Cancer Patients
Led by Inah Kim · Updated on 2025-12-22
40
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Prospective Study on ICG Lymphoscintigraphy Changes Before and After Radiotherapy in Breast Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female, 18 years or older
- Pathologically confirmed stage I-III breast cancer
- Scheduled to receive postoperative radiotherapy
You will not qualify if you...
- Previous or current lymphedema
- Prior radiotherapy to the same breast or underarm area
- History of neoadjuvant chemotherapy
- Severe systemic diseases such as heart, kidney, or liver failure
- Active infection
- Pregnancy or breastfeeding
- Allergy to indocyanine green (ICG) or iodine-based contrast agents
AI-Screening
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Trial Site Locations
Total: 1 location
1
Dongtan Sacred Heart Hospital
Hwaseong-si, Gyeonggido, South Korea, 18450
Actively Recruiting
Research Team
I
Inah Kim, M.D.,Ph.D
CONTACT
Y
Yongkyun Jung, M.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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