Clinical trial NCT05574907: Characterizing Breast Cancer With 68Ga-FAPI PET/CT (PFB-01)
Official title: Accuracy and Safety of 68Ga-FAPI PET/CT in the Diagnosis of Axillary Lymph Node Metastasis in Early Breast Cancer Patients: A Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2022-10-12
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Diagnostic Performance (1)
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Clinical Stage
timeFrame: Through study completion, an average of 1 year
measure: Diagnostic Performance (2)
timeFrame: Through study completion, an average of 1 year
measure: Safety
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Li Huo, M.D.
role: PRINCIPAL_INVESTIGATOR
References: