Breast Cancer Invasive, Node Positive Breast Cancer
Conditions
Keywords
68Ga-FAPi-46 PET/CT
Brief 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.
Detailed description
All patients affected by newly diagnosed, clinically N-positive BC that have already undergone a baseline 2-deoxy-2-\[fluorine-18\]fluoro-D-glucose (18F-FDG) PET/CT (T1) will be screened for eligibility. Patients who will meet all inclusion/exclusion criteria will be considered eligible and asked to participate to the study after signing the informed consent form. Patients' eligibility will be evaluated by the referent nuclear medicine physician (T2). Considering the clinical experience of the investigators, we expect to complete patient enrolment in 12 months after study accrual
Interventions
PROCEDURE68Ga-FAPi-46 PET/CT
Study participants will undergo baseline assessments at enrollment with 68Ga-FAPi-46 PET/CT
Sponsors
European Institute of Oncology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of 68Ga-FAPi PET/CT and 18F-FDG PET/CT positivity rate | 3 months | Comparison of 68Ga-FAPi PET/CT and 18F-FDG PET/CT of positivity rate (percentage of detection of metastatic patients) |
Countries
Italy
Contacts
Primary ContactFrancesco Ceci
Outcome results
None listed