Status:
UNKNOWN
Lidocaine Mucilage-ICG as an Optical Agent for Tumor Delineation During Breast-conserving Surgery
Lead Sponsor:
Shantou Central Hospital
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Around 15%-30% of patients receiving breast-conserving surgery (BCS) for invasive breast carcinoma or ductal carcinoma in situ (DCIS) need a reoperation due to tumor-positive margins at final histopat...
Eligibility Criteria
Inclusion
- Female at least 18 years old
- Histologically or cytologically confirmed breast carcinoma
- Patients planned to receive a breast-conserving surgery
- Patients received a preoperative breast magnetic resonance imaging
- Informed consent form understood and signed
- Patient agrees to all follow-up visits
- Eastern Cooperative Oncology Group(ECOG) performance status 0 to 1 within 14 days of study entry
- Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the surgery
Exclusion
- Psychiatric or other condition that may interfere with the study
- Known allergy or contraindication to any study drug
- Patients received neoadjuvant therapies
- Patients received an excision biopsy of the tumor
- Breast feeding period
- Pregnant (female of childbearing potential only)
Key Trial Info
Start Date :
August 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04438577
Start Date
August 20 2020
End Date
January 1 2024
Last Update
October 22 2020
Active Locations (1)
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1
Shantou Central Hospital
Shantou, Guangdong, China, 515300