Prospective Study on ICG Lymphoscintigraphy Changes Before and After Radiotherapy in Breast Cancer Patients
NCT ID: NCT07297927
Last Updated: 2025-12-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
40 participants
OBSERVATIONAL
2025-11-05
2028-10-18
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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Inah Kim
OTHER
Responsible Party
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Inah Kim
Clinical Assistant Professor
Locations
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Dongtan Sacred Heart Hospital
Hwaseong-si, Gyeonggido, South Korea
Countries
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Central Contacts
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Facility Contacts
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Inah Kim, M.D.,Ph.D
Role: primary
Yongkyun Jung, M.D.
Role: backup
Other Identifiers
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2025-10-008
Identifier Type: -
Identifier Source: org_study_id