ICG imaging of lymphatic changes before and after breast radiotherapy
Official title: Prospective Study on ICG Lymphography Changes Before and After Radiotherapy in Breast Cancer Patients
Run by Dongtan Sacred Heart Hospital · NCT07297927 · Data updated 2026-11-12
This study will use ICG lymphography to see if early lymphatic changes after radiotherapy predict later arm swelling in women treated for stage I–III breast cancer.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 40 (estimated) |
| Sponsor | Dongtan Sacred Heart Hospital Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Hwaseong-si, Gyeonggido) |
| Status | Recruiting |
| Started | November 5, 2025 |
| Main results expected | April 2, 2027 |
| Study ends | October 18, 2028 |
| Registry record updated | September 28, 2026 |
| Trial ID | NCT07297927 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 18 or older with pathologically confirmed stage I–III breast cancer who are scheduled to receive postoperative radiotherapy and do not have prior ipsilateral radiotherapy or existing lymphedema are ideal candidates.
✕Probably not a fit
Patients with prior or current lymphedema, previous ipsilateral radiotherapy, allergy to ICG/iodine, pregnancy or severe systemic organ failure would be excluded and are unlikely to benefit from this imaging-based observational protocol.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study will perform indocyanine green (ICG) lymphography on female patients with pathologically confirmed stage I–III breast cancer before radiotherapy and again 4–6 weeks after completing radiotherapy. Participants will receive a small subcutaneous injection of ICG dye and undergo near-infrared imaging to visualize lymphatic flow and vessel function. There is no intervention arm—all imaging is done alongside standard postoperative radiotherapy—to characterize early changes that might lead to breast-cancer-related lymphedema. The study excludes patients with prior ipsilateral radiotherapy, existing lymphedema, pregnancy, severe organ failure, or allergy to ICG/iodine.
Why it matters
Potential benefit: If successful, the study could identify patients at higher risk of breast-cancer-related lymphedema early so they can receive preventive rehabilitation before significant swelling develops.
How similar studies have gone: Smaller studies have shown that ICG lymphography can detect early lymphatic abnormalities and correlate with lymphedema risk, but prospective evidence specifically linking post-radiotherapy ICG changes to later arm swelling remains limited.
Who can join: the full rules
Show full inclusion / exclusion 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 * Severe systemic diseases (heart, renal, hepatic failure) * Active infection * Pregnancy or lactation * Allergy to indocyanine green (ICG) or iodine-based contrast agents
Where it's running
-
Dongtan Sacred Heart Hospital
Hwaseong-si, Gyeonggido, South Korea Recruiting
Study contacts
- Study coordinator: Inah Kim, M.D.,Ph.D
- Email: inahsylvia@gmail.com
- Phone: 82-10-2937-6852
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.