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

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.

Eligibility

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.

Conditions4

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