Clinical trial · Interventional
Sentinel Node Biopsy Vs Observation After Axillary PET
Sentinel Node Biopsy Vs Observation After Axillary PET Examination
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SLNB is spared | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Observation group( SLNB is spared)
- description
- In the second stage, sentinel lymph node biopsy will be spared in the patients with negative preoperative axillary assessment.
- interventionNames
- Procedure: SLNB is spared
Primary outcomes (3)
- measure
- stage 1: negative predictive value
- timeFrame
- 6 months
- description
- negative predictive value of LymphPET in breast cancer patients with a negative preoperative axillary assessment
- measure
- stage 2: D-DFS(distant disease-free survival)
- timeFrame
- 5 years
- description
- D-DFS of patients with negative preoperative axillary assessment(including LymphPET and other imaging examination) and for whom axillary surgery is spared
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDQu FL, Cheng JY, Jiang SH, Zhang Q, Liu GY, Cao AY, Wu J, Yu KD, Di GH, Li JJ, Shao ZM. Omission of Axillary Surgery in Patients with Negative Axillary Evaluation Integrated with LymphPET: A Prospective Clinical Study. Ann Surg Oncol. 2026 Jun;33(6):5558-5566. doi: 10.1245/s10434-026-19342-5. Epub 2026 Feb 27. PMID 41760969