Using a fluorescent dye to improve breast-conserving surgery outcomes in breast cancer patients
Surgical Outcome of Breast Conserving Surgery Using Indocyanine Green Fluorescence in Breast Cancer Patients After Preoperative Chemotherapy: a Prospective Study
This study is testing a special dye to see if it can help doctors find hard-to-locate breast tumors better during surgery for breast cancer patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | National Cancer Center, Korea Government |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Goyang-si, Gyeonggi-do) |
| Trial ID | NCT06780735 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of indocyanine green (ICG), a fluorescent dye, to enhance the localization of non-palpable breast lesions in patients undergoing breast-conserving surgery (BCS) after neoadjuvant chemotherapy. Traditional localization methods have limitations, particularly for patients with larger breasts, and ICG aims to provide a safer and more effective alternative. The study will assess the margin-positive rate using this innovative localization technique, potentially improving surgical outcomes for breast cancer patients.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with locally advanced breast cancer who are eligible for breast-conserving surgery after neoadjuvant chemotherapy.
Not a fit: Patients who require total mastectomy or have no residual mass on imaging may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved surgical precision and reduced rates of cancer recurrence in breast cancer patients.
How similar studies have performed: While the use of ICG in surgical settings has shown promise, this specific application in breast cancer surgery is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The Patient with locally advanced breast cancer who is eligible for breast-conserving surgery after receiving neoadjuvant chemotherapy * Aged over 18 years old * ECOG performance status: 0 or 1 * The patients with written informed consent Exclusion Criteria: * The patient who requires total mastectomy after receiving neoadjuvant chemotherapy * The patient with no residual mass on ultrasonography or only with microcalcifications * Pregnant or lactating patient * The patient with a disability to understand and provide consent * The patient with severe allergic history to indocyanine green * Iodine-sensitive patient
Where this trial is running
Goyang-si, Gyeonggi-do
- National Cancer Center — Goyang-si, Gyeonggi-do, South Korea (Recruiting)
Study contacts
- Principal investigator: Seeyoun Lee, MD — National Cancer Center, Korea
- Study coordinator: Seeyoun Lee, MD
- Email: seeyoun@ncc.re.kr
- Phone: +82-31-920-1736
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.