Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
1528 participants
INTERVENTIONAL
2019-09-04
2027-09-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Observation group( SLNB is spared)
In the second stage, sentinel lymph node biopsy will be spared in the patients with negative preoperative axillary assessment.
SLNB is spared
SLNB is spared in patients with negative preoperative axillary assessment(including LymphPET and other imaging examinations)
Interventions
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SLNB is spared
SLNB is spared in patients with negative preoperative axillary assessment(including LymphPET and other imaging examinations)
Eligibility Criteria
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Inclusion Criteria
1. female
2. ≥18 years old
3. invasive ductal carcinoma or DCIS proved by core needle biopsy
4. tumor size ≤ 5cm
5. negative preoperative axillary assessment(including body examination, ultrasound and MR examination)
6. patients is accessible for the following axillary surgery and pathological test(including sentinel lymph node biopsy and axillary lymph node dissection)
stage 2:
1. female
2. ≥18 years old
3. invasive carcinoma proved by core needle biopsy
4. has plan for breast conserving surgery and adjuvant radiation after surgery
5. negative preoperative axillary assessment(including body examination, ultrasound and axillary PET mSUV\<0.27)
6. patients is accessible for the follow up
Exclusion Criteria
1. distant metastases
2. in the procedure of neoadjuvant therapy
3. positive preoperative axillary assessment (including body examination, ultrasound and MR examination)
4. pregnancy or breastfeeding
5. axillary biopsy or axillary surgery before LymphPET
6. suffer from diabetes mellitus and without well control of bloodglucose
7. previous malignancy
8. allergic to tracer of LymphPET
stage 2:
1. distant metastases
2. in the procedure of neoadjuvant therapy
3. positive preoperative axillary assessment (including body examination, ultrasound and PET mSUV≥0.27)
4. pregnancy or breastfeeding
5. axillary biopsy or axillary surgery before LymphPET
6. suffer from diabetes mellitus and without well control of bloodglucose
7. previous malignancy
8. allergic to tracer of LymphPET
18 Years
FEMALE
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Zhimin Shao
professor
Principal Investigators
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Zhi-Min Shao
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Zhiming Shao
Role: primary
Other Identifiers
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SCHBCC-SOAPET
Identifier Type: -
Identifier Source: org_study_id
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