Characterizing Breast Cancer With Al18F-NOTA-FAPI-04 PET/CT (PFB-02)

Study Overview
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Brief Summary
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Fibroblast activation protein (FAP) is overexpressed in cancer-associated fibroblasts (CAFs), which constitute a major proportion of cells within the tumor microenvironment, especially in breast cancer. Previous studies have demonstrated that FAPI PET/CT performs well in cases of epithelial tumors, including breast cancer. This prospective study is going to investigate the performance and value of Al18F-NOTA-FAPI-04 PET/CT in patients with breast cancer.

Detailed Description
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Breast cancer is a complex, heterogeneous disease comprising numerous distinct biological subtypes characterized by variant pathobiological features and clinical behaviors. 18F-fluorodeoxyglucose (18F-FDG) PET/CT, an essential imaging modality in the characterization of metabolism within the tumor, has successfully evolved in the diagnosis, staging, and assessment of treatment response in patients with breast cancer. Cancer-associated fibroblasts (CAFs) are a crucial component of the tumor stroma with diverse functions. Fibroblast activation protein (FAP), a type II membrane-bound glycoprotein from the dipeptidyl peptidase-4 family, is highly expressed in the CAFs of several epithelial carcinomas, including breast cancer, coupled with relatively low expression in normal tissue. Based on this characteristic, many small-molecule inhibitors of FAP (FAPIs) labeled with radioactive tracers (68Ga, 18F, or 177Lu) have been synthesized as theranostic radiotracers for cancer. Previous studies on FAPI PET/CT tumor imaging have focused on the 68Ga radionuclide rather than 18F. As 18F-labeled FAPI has more favorable physical properties, high production capacity, and good imaging characteristics, it may be an ideal agent for PET imaging. Therefore, this study aims to evaluate the performance and value of Al18F-NOTA-FAPI-04 PET/CT in patients with breast cancer.

Official Title
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Accuracy and Safety of Al18F-NOTA-FAPI-04 PET/CT in the Diagnosis of Axillary Lymph Node Metastasis in Early Breast Cancer Patients: A Prospective Cohort Study

Conditions
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Breast Cancer

Intervention / Treatment
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* Diagnostic Test: Al18F-NOTA-FAPI-04 PET/CT scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18-80 years old; newly diagnosed BC confirmed by biopsy or with BI-RADS category 4C or 5 lesions by US or MG; BC clinical stagecT1-3 cN0-3 M0; no prior treatment for BC. Exclusion Criteria: pregnancy; breastfeeding; patients who were unwilling to undergo PET/CT scans.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Al18F-NOTA-FAPI-04 PET/CT<br>Inject Al18F-NOTA-FAPI-04 and then perform PET/CT scan. | Diagnostic Test: Al18F-NOTA-FAPI-04 PET/CT scan<br>* Patients enrolled underwent PET/CT after injection of Al18F-NOTA-FAPI-04 to image lesions of breast cancer.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic Performance (1) | Diagnostic performance including sensitivity, specificity, accuracy, positive predictive value and negative predictive value of Al18F-NOTA-FAPI-04 PET/CT in the detection of ALN metastasis according to the pathological reference standard on a per-patient basis, compared with 18F-FDG PET/CT and ultrasound. | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Stage | Clinical stage changed by Al18F-NOTA-FAPI-04 PET/CT compared to 18F-FDG PET/CT. | Through study completion, an average of 1 year | 
| Diagnostic Performance (2) | Diagnostic performance of ALN metastasis of Al18F-NOTA-FAPI-04 PET/CT with or without previous biopsy on breast lesion. | Through study completion, an average of 1 year | 
| Safety | Short-term adverse effects (AEs) after Al18F-NOTA-FAPI-04 injection. | Through study completion, an average of 1 year |