Clinical trials / NCT06790264
Recruiting

Exploring the Tumor Micro-Environment with 68Ga-FAPi-46 PET/CT in Breast Cancer

This study is a prospective, non-interventional, open-label study to evaluate the glucose metabolism and the expression of the imaging agent 68 Gallium-Fibroblast Activation Protein Inhibitor-46 (68Ga-FAPi-46) with PET imaging, in woman affected by Breast Cancer (BC) and referred to diagnostic imaging work-up prior to primary therapy.

ClinicalTrials.gov IDNCT06790264
PhaseNA
Enrollment92
SponsorEuropean Institute of Oncology
Age18 Years
SexFEMALE
I'm interested View official listing

Conditions studied

Breast Cancer Invasive, Node Positive Breast Cancer

About this study

This study is a prospective, non-interventional, open-label study to evaluate the glucose metabolism and the expression of the imaging agent 68 Gallium-Fibroblast Activation Protein Inhibitor-46 (68Ga-FAPi-46) with PET imaging, in woman affected by Breast Cancer (BC) and referred to diagnostic imaging work-up prior to primary therapy.

Interventions

Primary outcomes

Eligibility information

Inclusion Criteria: * Newly diagnosed, biopsy proven breast cancer; * Diagnosis of invasive breast cancer; * Tumor diameter more than 2 centimeters; * Radiological evidence of axillary nodes involvement; * 18F-FDG PET/CT performed as baseline diagnostic procedure, during routine diagnostic work-up; * 68Ga-FAPi-46 PET/CT performed within 4 weeks from 18F-FDG PET/CT; * Patients suitable to primary treatment (surgery or neo-adjuvant therapy); * 68Ga-FAPi-46 PET/CT performed within 8 weeks from primary treatment; * Female patients; * Age ≥18; * Willing to sign informed consent form. Exclusion Criteria: * Pregnant or nursing patients; * Unable to stay flat and cannot tolerate PET scan; * Sample tissue from biopsy unavailable for assessing Fibroblast Activation Protein (FAP) expression; * Eastern Cooperative Oncology Group (ECOG) performance status ≥2.

Study locations

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.