Using 68Ga-FAPi-46 PET/CT to study breast cancer
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
This study is testing a new imaging method using a special agent to see if it can help women with node-positive breast cancer get better information about their tumors before starting treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 92 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | European Institute of Oncology Academic / other |
| Locations | 1 site (Milan, Italy) |
| Trial ID | NCT06790264 on ClinicalTrials.gov |
What this trial studies
This study evaluates the glucose metabolism and expression of the imaging agent 68Ga-FAPi-46 in women diagnosed with node-positive breast cancer. Participants will undergo a baseline 18F-FDG PET/CT scan followed by a 68Ga-FAPi-46 PET/CT within a specified timeframe. The study aims to gather data on the tumor micro-environment to improve diagnostic imaging prior to primary therapy. Eligible patients will be screened and enrolled after providing informed consent, with an expected enrollment period of 12 months.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with newly diagnosed, biopsy-proven invasive breast cancer and evidence of axillary node involvement.
Not a fit: Patients who are pregnant, nursing, or have an ECOG performance status of 2 or higher may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of breast cancer imaging and improve treatment planning.
How similar studies have performed: Other studies using PET imaging in cancer diagnostics have shown promising results, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Milan, Italy
- European Institute of Oncology — Milan, Italy, Italy (Recruiting)
Study contacts
- Principal investigator: Francesco Ceci, MD — European Istitute of Oncology
- Study coordinator: Francesco Ceci
- Email: francesco.ceci@ieo.it
- Phone: +390257489315
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.