Clinical trial NCT06559371: 68Ga FAPI PET/CT Evaluation of Axillary Lymph Node Status After Neoadjuvant Therapy in Patients With Clinical Axillary Lymph Node Positive Breast Cancer
Official title: 68Ga FAPI PET/CT Evaluation of Axillary Lymph Node Status After Neoadjuvant Therapy in Patients With Clinical Axillary Lymph Node Positive Breast Cancer
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: BREAST CANCER
PET/CT
Keywords: BREAST CANCER
PET/CT
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2024-08-19
Enrollment: 51
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * 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

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.

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

Primary outcomes:
measure: Sensitivity and specificity of 68Ga FAPI PET/CT in predicting residual axillary lymph node lesions after neoadjuvant therapy
timeFrame: up to the end of surgery
Secondary outcomes:
measure: Sensitivity and specificity of 68Ga FAPI PET/CT in predicting pathological complete response (Breast pCR) of breast lesions in neoadjuvant therapy
timeFrame: up to the end of surgery
measure: Sensitivity and specificity of 68Ga FAPI PET/CT in predicting objective response rate (ORR) of neoadjuvant therapy
timeFrame: up to the end of surgery
Other outcomes:
Locations:
Study officials:
affiliation: Shanghai Jiao Tong University, School of Medicine, Affiliated Ruijin Hospital
name: Xiaosong Chen
role: PRINCIPAL_INVESTIGATOR
References: