BREAST CANCER, PET/CT
Conditions
Keywords
BREAST CANCER, PET/CT
Brief summary
The goal of this observational study is to learn whether 68Ga-FAPI PET/CT may be used as a new effective methods for evaluating axillary lymph node efficacy after neoadjuvant treatment for breast cancer. The main question it aims to answer is: Could 68Ga-FAPI PET/CT effectively evaluate axillary lymph node after neoadjuvant treatment for breast cancer? Participants will have a 68Ga-FAPI PET/CT test between last neoadjuvant therapy and surgery.
Detailed description
Previous studies have shown that compared with conventional 18F-FDG PET/CT, 68Ga-FAPI PET/CT has the characteristics of not being affected by blood glucose, good tumor specificity, and high tumor-to-background ratio, and studies have shown that 68Ga- FAPI PET/CT can detect parts of breast cancer primary lesions and lymph node metastases with low 18F-FDG uptake, thereby increasing the lesion detection rate and improving the sensitivity of imaging examinations. Therefore, 68Ga-FAPI PET/CT may be used as a new effective methods for evaluating axillary lymph node efficacy after neoadjuvant treatment for breast cancer. Therefore, we plan to conduct this study to explore the ability of 68Ga-FAPI PET/CT to detect residual disease in axillary lymph nodes in patients with clinically positive axillary node (cN+) breast cancer after neoadjuvant treatment. By this way, we may explore an accurate and non-invasive assessment of axillary lymph node status after neoadjuvant therapy in breast cancer patients.
Interventions
None listed
Sponsors
Kunwei Shen
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female patients aged 18 and above * ECOG score 0-2 points * Pathological confirmation of malignant breast tumor * Clinical axillary lymph node positivity (cN+) * Completed at least 3 courses of neoadjuvant therapy and subjected to undergo surgical treatment * Informed consent form signed
Exclusion criteria
* Distant metastasis * Unable to complete the proposed neoadjuvant therapy plan * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and specificity of 68Ga FAPI PET/CT in predicting residual axillary lymph node lesions after neoadjuvant therapy | up to the end of surgery | Sensitivity and specificity of 68Ga FAPI PET/CT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and specificity of 68Ga FAPI PET/CT in predicting pathological complete response (Breast pCR) of breast lesions in neoadjuvant therapy | up to the end of surgery | Sensitivity and specificity of 68Ga FAPI PET/CT in predicting pathological complete response (Breast pCR) of breast lesions in neoadjuvant therapy |
| Sensitivity and specificity of 68Ga FAPI PET/CT in predicting objective response rate (ORR) of neoadjuvant therapy | up to the end of surgery | Sensitivity and specificity of 68Ga FAPI PET/CT in predicting objective response rate (ORR) of neoadjuvant therapy |
| 68Ga FAPI PET/CT in predicting invasive disease free survival after neoadjuvant therapy | From enrollment to the end of treatment at 3 years | 68Ga FAPI PET/CT in predicting invasive disease free survival after neoadjuvant therapy |
| 68Ga FAPI PET/CT in predicting overall survival after neoadjuvant therapy | From enrollment to the end of treatment at 3 years | 68Ga FAPI PET/CT in predicting overall survival after neoadjuvant therapy |
Countries
China
Contacts
Primary ContactXiaosong Chen
Outcome results
None listed