Sentinel Node Biopsy Vs Observation After Axillary PET Examination

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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 (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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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

Locations
Other Locations
China
Fudan University Shanghai Cancer Center
RECRUITING
Shanghai
Contact Information
Primary
Zhi-Min Shao
zhimingshao@yahoo.com
086-021-64175590
Time Frame
Start Date: 2019-09-04
Estimated Completion Date: 2027-09-01
Participants
Target number of participants: 1528
Treatments
Experimental: Observation group( SLNB is spared)
In the second stage, sentinel lymph node biopsy will be spared in the patients with negative preoperative axillary assessment.
Related Therapeutic Areas
Sponsors
Leads: Fudan University

This content was sourced from clinicaltrials.gov