Sentinel Node Biopsy Vs Observation After Axillary PET (SOAPET)

Fudan University

Status: Enrolling

Conditions: Breast Cancer

Treatments: Procedure: SLNB is spared

Study type: Interventional

Funder types: Other

Identifiers

NCT04072653

SCHBCC-SOAPET

Details and patient eligibility

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.

Enrollment: 1,528 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

stage 1:

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

stage 1:

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,528 participants in 1 patient group

Observation group( SLNB is spared)

Experimental group

Description:

In the second stage, sentinel lymph node biopsy will be spared in the patients with negative preoperative axillary assessment.

Treatment:

Procedure: SLNB is spared