Exploring the Tumor Micro-Environment with 68Ga-FAPi-46 PET/CT in Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 68Ga-FAPi-46 PET/CT.
- Who it may be relevant to
- Registry conditions: Breast Cancer Invasive, Node Positive Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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
- Procedure 68Ga-FAPi-46 PET/CT
Study participants will undergo baseline assessments at enrollment with 68Ga-FAPi-46 PET/CT
Primary outcome measures
- Comparison of 68Ga-FAPi PET/CT and 18F-FDG PET/CT positivity rate [Time frame: 3 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Italy · 1 center
- European Institute of Oncology — Milan
Identifiers
NCT: NCT06790264 · UID 4047