Patients with estrogen receptor-positive breast cancer
Conditions
Interventions
Experimental Group (SLNB Exemption):18F-FDG/18F-FES PET-CT guided exemption of sentinel lymph node biopsy (SLNB)
Control Group (Routine SLNB):Routine sentinel lymph node biopsy (SLNB)
Sponsors
The First Affiliated Hospital of Chongqing Medical University
Eligibility
Sex/Gender
Female
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Patients with pathologically confirmed ER-positive invasive breast cancer; 2. Female; 3. Aged 18 to 80 years; 4. Clinical stage cT1-2N0M0 (negative findings on ultrasound, chest X-ray, mammography, and MRI; 5. Candidates scheduled for surgical treatmen; 6. Patients who undergo PET/CT examination.
Exclusion criteria
Exclusion criteria: 1. Preoperative pN1 stage or higher; 2. Distant metastasis; 3. History of cancer; 4. Ongoing pregnancy or lactation period; 5. Previous history of ipsilateral axillary surgery; 6. Receive endocrine therapy recently; 7. Alcohol allergy; 8. Refusal to undergo PET/CT imaging; 9. Planned neoadjuvant therapy (chemotherapy or endocrine therapy); 10. Patients who are unable to obtain informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic accuracy (sensitivity and specificity) of PET-CT for evaluating axillary lymph node metastasis; | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-year Disease-Free Survival (DFS);Concordance of ER status evaluated by 18F-FES PET-CT; | — |
Countries
China
Contacts
Public ContactLiu Shengchun
The First Affiliated Hospital of Chongqing Medical University
Outcome results
None listed