NCT07297927 Prospective Study on ICG Lymphoscintigraphy Changes Before and After Radiotherapy in Breast Cancer Patients
| NCT ID | NCT07297927 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Inah Kim |
| Condition | Breast Neoplasms |
| Study Type | OBSERVATIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-11-05 |
| Primary Completion | 2026-02-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 40 participants in total. It began in 2025-11-05 with a primary completion date of 2026-02-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Female, ≥18 years old Pathologically confirmed stage I-III breast cancer Scheduled to receive postoperative radiotherapy (RT) Exclusion Criteria: * Previous or current lymphedema Prior radiotherapy to the ipsilateral breast or axilla History of neoadjuvant chemotherapy Severe systemic diseases (heart, renal, hepatic failure) Active infection Pregnancy or lactation Allergy to indocyanine green (ICG) or iodine-based contrast agents
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07297927 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07297927 currently recruiting?
Yes, NCT07297927 is actively recruiting participants. Contact the research team at inahsylvia@gmail.com for enrollment information.
Where is the NCT07297927 trial being conducted?
This trial is being conducted at Hwaseong-si, South Korea.
Who is sponsoring the NCT07297927 clinical trial?
NCT07297927 is sponsored by Inah Kim. The trial plans to enroll 40 participants.