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
European Institute of Oncology
92 participants
Nov 1, 2024
INTERVENTIONAL
Conditions
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 Criteria11
- Newly diagnosed, biopsy proven breast cancer;
- Diagnosis of invasive breast cancer;
- Tumor diameter more than 2 centimeters;
- Radiological evidence of axillary nodes involvement;
- F-FDG PET/CT performed as baseline diagnostic procedure, during routine diagnostic work-up;
- Ga-FAPi-46 PET/CT performed within 4 weeks from 18F-FDG PET/CT;
- Patients suitable to primary treatment (surgery or neo-adjuvant therapy);
- Ga-FAPi-46 PET/CT performed within 8 weeks from primary treatment;
- Female patients;
- Age ≥18;
- Willing to sign informed consent form.
Exclusion Criteria4
- 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.
Interventions
Study participants will undergo baseline assessments at enrollment with 68Ga-FAPi-46 PET/CT
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06790264