68Ga-FAPI-46 versus 18F-FDG PET imaging in ER-positive 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 Phase 2 interventional study enrolls women with histologically confirmed ER-positive locally advanced, recurrent, or metastatic breast cancer who are scheduled for 18F-FDG PET/CT or PET/MRI staging. Participants undergo 68Ga-FAPI-46 PET/CT or PET/MRI in addition to the standard 18F-FDG imaging so the two tracers can be directly compared for lesion detection and disease extent. 68Ga-FAPI-46 targets fibroblast activation protein in the tumor stroma, which is frequently overexpressed in epithelial tumors, and prior studies have shown higher detection rates with FAPI tracers overall. This trial specifically tests whether that detection advantage applies to the ER-positive subtype and could change staging outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Female patient with histopathologically proven ER+ breast cancer.
* Diagnosed with locally advanced (primary tumor \>5 cm and/or presence of axillary lymph node metastases) or recurrent breast cancer, or metastatic breast cancer for which 18F-FDG PET/CT or 18F-FDG PET/MRI staging is performed.
* Willing and able to undergo the study procedures.
* Has personally provided written informed consent.

Exclusion Criteria:

* Age \<18
* Pregnancy
* Patients with secondary malignancies (except non-melanoma skin cancer)
* No 18F-FDG PET/CT or 18F-FDG PET/MRI scan.
* Contra-indications for PET/MRI such as pacemaker, aneurysm clips, metallic device in their body, severe claustrophobia, and severe obesity
* Chronic inflammatory disease such as rheumatoid arthritis.
* Patients with severe hepatic or renal impairment (eGFR ≤45mL/min/1.73m²)
* Inability to provide informed consent.

Where it's running

• Maastricht University Medical Center+
  Maastricht, Netherlands Recruiting

Study contacts

• Study coordinator: Thiemo JA van Nijnatten, MD, PhD
• Email: thiemo.nijnatten@mumc.nl
• Phone: +31433876910

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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.