Characterizing Breast Cancer With 68Ga-FAPI PET/CT (PFB-01)

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Active, not recruiting

Conditions: Breast Cancer

Treatments: Diagnostic Test: 68Ga-FAPI PET/CT scan

Study type: Interventional

Funder types: Other

Identifiers

NCT05574907

PekingUMCH-FAPI-BC-1

Details and patient eligibility

About

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. 68Ga-FAPI has been developed as a tumor-targeting agent. This prospective study is going to investigate the performance and value of 68Ga-FAPI PET/CT in patients with breast cancer.

Full 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. Gallium-68 (68Ga)-conjugated FAP inhibitor (FAPI), a new radiotracer targeting FAP, has been developed for targeting FAP and tumor-stromal visualization. With its fast renal clearance and high tumor-to-background ratio, 68Ga-FAPI has been successfully validated in multi-types of tumors. This study aims to evaluate the performance and value of 68Ga- FAPI PET/CT in patients with breast cancer.

Enrollment: 72 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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72 participants in 1 patient group

68Ga-FAPI PET/CT

Experimental group

Description:

Inject 68Ga-FAPI and then perform PET/CT scan.

Treatment:

Diagnostic Test: 68Ga-FAPI PET/CT scan