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

Last updated: December 22, 2023
Sponsor: Peking Union Medical College Hospital
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Cancer

Breast Cancer

Treatment

68Ga-FAPI PET/CT scan

Clinical Study ID

NCT05574907
PekingUMCH-FAPI-BC-1
  • Ages 18-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • age 18-80 years old;
  • newly diagnosed BC confirmed by biopsy or with BI-RADS category 4C or 5 lesions by USor MG;
  • BC clinical stagecT1-3 cN0-3 M0;
  • no prior treatment for BC.

Exclusion

Exclusion Criteria:

  • pregnancy;
  • breastfeeding;
  • patients who were unwilling to undergo PET/CT scans.

Study Design

Total Participants: 72
Treatment Group(s): 1
Primary Treatment: 68Ga-FAPI PET/CT scan
Phase:
Study Start date:
May 01, 2021
Estimated Completion Date:
February 01, 2024

Study 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.

Connect with a study center

  • Peking Union Medical College Hospital

    Beijing, Beijing 100730
    China

    Site Not Available

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