Actively Recruiting
Exploring the Tumor Micro-Environment with 68Ga-FAPi-46 PET/CT in Breast Cancer
Led by European Institute of Oncology · Updated on 2025-01-27
92
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Exploring the Tumor Micro-Environment with 68Ga-FAPi-46 PET/CT in Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 for primary treatment (surgery or neo-adjuvant therapy)
- 68Ga-FAPi-46 PET/CT performed within 8 weeks from primary treatment
- Female patients
- Age 18 years or older
- Willing to sign informed consent form
You will not qualify if you...
- 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 or higher
AI-Screening
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Trial Site Locations
Total: 1 location
1
European Institute of Oncology
Milan, Italy, Italy, 20141
Actively Recruiting
Research Team
F
Francesco Ceci
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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