Status:
RECRUITING
Sentinel Node Biopsy Vs Observation After Axillary PET
Lead Sponsor:
Fudan University
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Several researches have proved that avoiding axillary surgery does not worsen the outcome of breast cancer patients with relatively low risk. Based on the routine axillary imaging evaluation (ultrasou...
Eligibility Criteria
Inclusion
- stage 1:
- female
- ≥18 years old
- invasive ductal carcinoma or DCIS proved by core needle biopsy
- tumor size ≤ 5cm
- negative preoperative axillary assessment(including body examination, ultrasound and MR examination)
- patients is accessible for the following axillary surgery and pathological test(including sentinel lymph node biopsy and axillary lymph node dissection)
- stage 2:
- female
- ≥18 years old
- invasive carcinoma proved by core needle biopsy
- has plan for breast conserving surgery and adjuvant radiation after surgery
- negative preoperative axillary assessment(including body examination, ultrasound and axillary PET mSUV\<0.27)
- patients is accessible for the follow up
Exclusion
- stage 1:
- distant metastases
- in the procedure of neoadjuvant therapy
- positive preoperative axillary assessment (including body examination, ultrasound and MR examination)
- pregnancy or breastfeeding
- axillary biopsy or axillary surgery before LymphPET
- suffer from diabetes mellitus and without well control of bloodglucose
- previous malignancy
- allergic to tracer of LymphPET
- stage 2:
- distant metastases
- in the procedure of neoadjuvant therapy
- positive preoperative axillary assessment (including body examination, ultrasound and PET mSUV≥0.27)
- pregnancy or breastfeeding
- axillary biopsy or axillary surgery before LymphPET
- suffer from diabetes mellitus and without well control of bloodglucose
- previous malignancy
- allergic to tracer of LymphPET
Key Trial Info
Start Date :
September 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2027
Estimated Enrollment :
1528 Patients enrolled
Trial Details
Trial ID
NCT04072653
Start Date
September 4 2019
End Date
September 1 2027
Last Update
July 13 2020
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032