None listed
Conditions
Interventions
Procedure/Surgery : This study compares the experimental group using Luminomark for pre-operative localization of breast lesions with the active control group using conventional dyes (indigocarmine or
Sponsors
Samsung Changwon Medical Center
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Patients diagnosed with invasive breast cancer or ductal carcinoma in situ (DCIS) who are determined to be eligible for breast-conserving surgery (BCS) based on preoperative evaluation. Patients who provide written informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: Patients scheduled to undergo total (or tissue-complete) mastectomy. Patients for whom preoperative localization is difficult or unfeasible to perform. Patients with lesions consisting solely of microcalcifications that are difficult to identify via ultrasound.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Margin-negative resection rate at the first excision (where a negative resection margin is defined as the absence of invasive breast cancer or ductal carcinoma in situ [DCIS] at the inked resection margin). | — |
Secondary
| Measure | Time frame |
|---|---|
| the rate of additional excision due to positive resection margins ;Breast excision ratio: calculated as the actual excised volume divided by the optimal excision volume;The failure rate of localization;Comparison of differences in the incidence of postoperative acute complications | — |
Countries
Korea, Republic of
Contacts
Public ContactHeejun Choi
Samsung Changwon Medical Center
Outcome results
None listed