Actively Recruiting
Sentinel Node Biopsy Vs Observation After Axillary PET
Led by Fudan University · Updated on 2020-07-13
1528
Participants Needed
1
Research Sites
417 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 (ultrasound and MR etc.) and latest dedicate lymph node PET (LymphPET), axillary nodal burden can be identified before operation. Therefore this prospective study are designed to evaluate the negative predictive value of LymphPET and to verify whether sentinel lymph node biopsy can be spared in patients with negative preoperative axillary assessment.
CONDITIONS
Official Title
Sentinel Node Biopsy Vs Observation After Axillary PET
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female
- 18 years old or older
- Diagnosed with invasive ductal carcinoma or ductal carcinoma in situ (DCIS) confirmed by core needle biopsy
- Tumor size 5 cm or smaller
- Negative preoperative axillary assessment including body examination, ultrasound, MRI, and LymphPET
- Accessible for the planned axillary surgery and pathological tests including sentinel lymph node biopsy and axillary lymph node dissection
- For stage 2: planned breast conserving surgery and adjuvant radiation after surgery
- Accessible for follow-up visits
You will not qualify if you...
- Presence of distant metastases
- Currently receiving neoadjuvant therapy
- Positive preoperative axillary assessment including body examination, ultrasound, MRI, or PET with mSUV ≥ 0.27
- Pregnant or breastfeeding
- Previous axillary biopsy or axillary surgery before LymphPET
- Diabetes mellitus without well-controlled blood glucose
- Previous malignancy
- Allergy to the tracer used in LymphPET
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
Z
Zhi-Min Shao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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