Using 68Ga-FAPi-46 PET/CT to study breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.