NCT06790264

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

Exploring the Tumor Micro-Environment with 68Ga-FAPi-46 PET/CT in Breast Cancer. a Phase II Study to Evaluate the Comparison of 68Ga-FAPi-46 and 18F-FDG Uptake in Patients with Different Breast Cancer Subtypes

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 92 (estimated)
• Sponsor: European Institute of Oncology · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

All patients affected by newly diagnosed, clinically N-positive BC that have already undergone a baseline 2-deoxy-2-\[fluorine-18\]fluoro-D-glucose (18F-FDG) PET/CT (T1) will be screened for eligibility. Patients who will meet all inclusion/exclusion criteria will be considered eligible and asked to participate to the study after signing the informed consent form. Patients' eligibility will be evaluated by the referent nuclear medicine physician (T2). Considering the clinical experience of the investigators, we expect to complete patient enrolment in 12 months after study accrual

Conditions

• Breast Cancer Invasive
• Node Positive Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	68Ga-FAPi-46 PET/CT	Study participants will undergo baseline assessments at enrollment with 68Ga-FAPi-46 PET/CT

Timeline

• Start date: 2024-11-01
• Primary completion: 2025-11-01
• Completion: 2025-11-01
• First posted: 2025-01-24
• Last updated: 2025-01-27

Locations

1 site across 1 country: Italy