Shanghai Jiao Tong University School of Medicine, Ruijin Hospital
Shanghai, Shanghai Municipality, 200020, China
Location status: Recruiting
NCT Number: NCT06559371
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.
Interested in participating?
Request Info18 year and older
Female
Observational
Shanghai, Shanghai Municipality, 200020, China
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: up to the end of surgery
Sensitivity and specificity of 68Ga FAPI PET/CT
Time frame: 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
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: From enrollment to the end of treatment at 3 years
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
Contact information is provided by the study sponsor or research team.
Kunwei Shen
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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