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

RecruitingNAAges 18 Years - anyFemaleEuropean Institute of Oncology
NCT06790264 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • 68Ga-FAPi-46 PET/CT
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Where

1 site
European Institute of Oncology
Milan, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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