Exploring the Tumor Micro-Environment with 68Ga-FAPi-46 PET/CT in Breast Cancer
Recruiting · NCT06790264 · Interventional (participants receive a specific treatment) · Lead sponsor: European Institute of Oncology
View the official record on ClinicalTrials.gov →Interventions studied
68Ga-FAPi-46 PET/CT
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.
Who can take part
Age range
18 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- European Institute of Oncology - Milan, Italy, Italy