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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05574920
• Other study ID #: PekingUMCH-FAPI-BC-2
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 10, 2022
• Est. completion date: February 1, 2024

Study information

• Verified date: December 2023
• Source: Peking Union Medical College Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 88
• Est. completion date: February 1, 2024
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Diagnostic Test:
• Al18F-NOTA-FAPI-04 PET/CT scan
Patients enrolled underwent PET/CT after injection of Al18F-NOTA-FAPI-04 to image lesions of breast cancer.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Safety	Short-term adverse effects (AEs) after Al18F-NOTA-FAPI-04 injection.	Through study completion, an average of 1 year