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

Not Applicable

Active, not recruiting

• Conditions: Breast Cancer
• Interventions: Diagnostic Test: 68Ga-FAPI PET/CT scan

• Registration Number: NCT05574907
• Lead Sponsor: Peking Union Medical College Hospital

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.

Study Timeline

• Study Start: 2021-05-01
• Study First Submitted: 2022-10-07
• Study First Submitted QC: 2022-10-10
• Study First Posted: 2022-10-12
• Primary Completion: 2023-10-31
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-22
• Last Update Posted: 2023-12-29
• Study Completion: 2024-02-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 72

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Diagnostic Performance (1)	Through study completion, an average of 1 year	Diagnostic performance including sensitivity, specificity, accuracy, positive predictive value and negative predictive value of 68Ga-FAPI 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.

Secondary Outcome Measures

Name	Time	Method
Safety	Through study completion, an average of 1 year	Short-term adverse effects (AEs) after 68Ga-FAPI injection.
Diagnostic Performance (2)	Through study completion, an average of 1 year	Diagnostic performance of ALN metastasis of 68Ga-FAPI PET/CT with or without previous biopsy on breast lesion.
Clinical Stage	Through study completion, an average of 1 year	Clinical stage changed by 68Ga-FAPI PET/CT compared to 18F-FDG PET/CT.

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China