ICG imaging of lymphatic changes before and after breast radiotherapy
Prospective Study on ICG Lymphoscintigraphy Changes Before and After Radiotherapy in Breast Cancer Patients
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 |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Dongtan Sacred Heart Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Hwaseong-si, Gyeonggido) |
| Trial ID | NCT07297927 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 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
Where this trial is running
Hwaseong-si, Gyeonggido
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.