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

NCT ID: NCT05574907

Last Updated: 2023-12-29

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2024-02-01

Brief 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. 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.

Detailed 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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

68Ga-FAPI PET/CT

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

Group Type: EXPERIMENTAL

68Ga-FAPI PET/CT scan

Intervention Type: DIAGNOSTIC_TEST

Patients with suspected breast cancer underwent 68Ga-FAPI PET/CT after an injection of 74-148 MBq (2-4 mCi) 68Ga-FAPI to image lesions of breast cancer.

Interventions

68Ga-FAPI PET/CT scan

Patients with suspected breast cancer underwent 68Ga-FAPI PET/CT after an injection of 74-148 MBq (2-4 mCi) 68Ga-FAPI to image lesions of breast cancer.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Li Huo, M.D.

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

PekingUMCH-FAPI-BC-1

Identifier Type: -

Identifier Source: org_study_id