About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female patients aged 18 and above

ECOG score 0-2 points

Pathological confirmation of malignant breast tumor

Clinical axillary lymph node positivity (cN+)

Disqualifiers

Distant metastasis

Unable to complete the proposed neoadjuvant therapy plan

Pregnancy

Trial 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

Trial design

Design model

Case-only

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

150 Participants

are grouped into 1 trial group

Group A: 68Ga-FAPI PET/CT

Trial outcomes

Primary outcomes

1

Sensitivity and specificity of 68Ga FAPI PET/CT in predicting residual axillary lymph node lesions after neoadjuvant therapy

Sensitivity and specificity of 68Ga FAPI PET/CT

Time frame

up to the end of surgery

Secondary outcomes

1

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

2

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

3

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

4

68Ga FAPI PET/CT in predicting overall survival after neoadjuvant therapy

Time frame

From enrollment to the end of treatment at 3 years

68Ga FAPI PET/CT Evaluation of Axillary Lymph Node Status After Neoadjuvant Therapy in Patients With Clinical Axillary Lymph Node Positive Breast Cancer

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial population

Trial design

Treatments tested in this trial

Trial groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts