68Ga-FAPI-46 versus 18F-FDG PET imaging in ER-positive breast cancer
18F-FDG Versus 68Ga-FAPI-46 as PET Tracer in ER-positive Breast Cancer - a Pilot Study.
This test compares whether 68Ga-FAPI-46 PET scans find more cancer spread than standard 18F-FDG PET scans in people with ER-positive breast cancer who need staging.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Maastricht University Medical Center Academic / other |
| Locations | 1 site (Maastricht) |
| Trial ID | NCT06335069 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Women with histopathologically proven ER-positive breast cancer who require staging for locally advanced (tumor >5 cm or nodal involvement), recurrent, or metastatic disease and who can undergo PET/CT or PET/MRI are appropriate candidates.
Not a fit: Patients who are pregnant, have severe hepatic or renal impairment, chronic inflammatory disease, secondary malignancies (except non-melanoma skin cancer), or contraindications to PET/MRI are unlikely to benefit or are ineligible.
Why it matters
Potential benefit: If successful, 68Ga-FAPI-46 imaging could reveal more distant metastases in ER-positive patients, enabling more accurate staging and improved treatment decisions.
How similar studies have performed: Previous non‑subtype‑specific studies have reported higher lesion detection with 68Ga-FAPI PET/CT compared with 18F-FDG PET/CT, but benefits specifically in ER-positive breast cancer have not yet been confirmed.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Maastricht
- Maastricht University Medical Center+ — Maastricht, Netherlands (Recruiting)
Study contacts
- Study coordinator: Thiemo JA van Nijnatten, MD, PhD
- Email: thiemo.nijnatten@mumc.nl
- Phone: +31433876910
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.