68Ga FAPI PET/CT Evaluation of Axillary Lymph Node Status After Neoadjuvant Therapy in Patients With Clinical Axillary Lymph Node Positive Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: BREAST CANCER, PET/CT. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Sensitivity and specificity of 68Ga FAPI PET/CT in predicting residual axillary lymph node lesions after neoadjuvant therapy [Time frame: up to the end of surgery]
Secondary outcome measures (4)
- Sensitivity and specificity of 68Ga FAPI PET/CT in predicting pathological complete response (Breast pCR) of breast lesions in neoadjuvant therapy [Time frame: up to the end of surgery]
- Sensitivity and specificity of 68Ga FAPI PET/CT in predicting objective response rate (ORR) of neoadjuvant therapy [Time frame: up to the end of surgery]
- 68Ga FAPI PET/CT in predicting invasive disease free survival after neoadjuvant therapy [Time frame: From enrollment to the end of treatment at 3 years]
- 68Ga FAPI PET/CT in predicting overall survival after neoadjuvant therapy [Time frame: From enrollment to the end of treatment at 3 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
China · 1 center
- Shanghai Jiao Tong University School of Medicine, Ruijin Hospital — Shanghai
Identifiers
NCT: NCT06559371 · RJBC-2403