NCT06790264 Exploring the Tumor Micro-Environment with 68Ga-FAPi-46 PET/CT in Breast Cancer
| NCT ID | NCT06790264 |
| Status | Recruiting |
| Phase | — |
| Sponsor | European Institute of Oncology |
| Condition | Breast Cancer Invasive |
| Study Type | INTERVENTIONAL |
| Enrollment | 92 participants |
| Start Date | 2024-11-01 |
| Primary Completion | 2025-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 92 participants in total. It began in 2024-11-01 with a primary completion date of 2025-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Francesco Ceci, MD
PRINCIPAL INVESTIGATOR
European Istitute of Oncology
Frequently Asked Questions
Who can join the NCT06790264 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Breast Cancer Invasive. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06790264 currently recruiting?
Yes, NCT06790264 is actively recruiting participants. Contact the research team at francesco.ceci@ieo.it for enrollment information.
Where is the NCT06790264 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT06790264 clinical trial?
NCT06790264 is sponsored by European Institute of Oncology. The principal investigator is Francesco Ceci, MD at European Istitute of Oncology. The trial plans to enroll 92 participants.
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