Exploring the Tumor Micro-Environment with 68Ga-FAPi-46 PET/CT in Breast Cancer
Recruiting now · Not applicable
Conditions studied: Breast Cancer Invasive, Node Positive Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT06790264
- Run by
- European Institute of Oncology
- People needed
- 92
- Starts
- 2024-11-01
- Expected to finish
- 2025-11-01
- Last updated by the study team
- 2025-01-27
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- European Institute of Oncology — Milan, Italy, Italy (enrolling)
Full record on ClinicalTrials.gov
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