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Clinical Trials in the Netherlands / NCT06335069
Recruiting Phase 2

18F-FDG Versus 68Ga-FAPI-46 as PET Tracer in ER-positive Breast Cancer.

NCT06335069 · tracked via the Priya Life Science Netherlands tracker
Sponsor
Maastricht University Medical Center
Phase
Phase 2
Started
2025-09-01
Last updated
2025-09-24

Condition(s) studied

Breast CancerBreast NeoplasmsBreast Diseases

Investigational drug(s) / intervention(s)

68Ga-FAPI-46 PET/CT and 68Ga-FAPI-46 PET/MRI

68Ga-FAPI-46 PET/CT and 68Ga-FAPI-46 PET/MRI: All participating patients will undergo an additional 68Ga-FAPI- 46 PET/CT and 68Ga-FAPI-46 PET/MRI scan prior to their breast cancer treatment.

Study summary

The extent of breast cancer is an important prognostic factor in patients diagnosed with this disease. Therefore, adequate staging at diagnosis is a requisite for optimal treatment. In all patients diagnosed with locally advanced breast cancer (LABC), distant staging using 18F-FDG PET/CT is recommended. However, the degree of metabolic uptake in the primary breast tumor is significantly lower in the ER+ subtype compared to HER2+ and triple negative breast cancer (TNBC). As a consequence, a suboptimal 18F-FDG uptake in ER+ breast cancer patients can potentially lead to missed distant metastases. Fibroblast-activating protein inhibitor (FAPI) is a recently developed radiotracer that binds to FAP, a stromal antigen overexpressed in more than 90% of epithelial-derived tumors and their metastases. Previous studies all show 68Ga-FAPI PET/CT to have a higher detection rate compared to 18F-FDG PET/CT. However, all previous studies were performed without considering breast cancer subtype. If the metabolic uptake by 68Ga-FAPI-46 is higher in ER+ breast cancer patients, more lesions will be detected, resulting in a more appropriate treatment for these patients. Therefore, in this pilot study, the investigators aim to compare the diagnostic performance of 18F-FDG with 68Ga-FAPI-46 as PET-tracer in ER+ breast cancer patients.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Maastricht University Medical Center+ Maastricht Netherlands Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06335069 on ClinicalTrials.gov ↗ ← All trials in the Netherlands