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Study identifier: NCT06335069 Synced from ClinicalTrials.gov · July 29, 2026
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18F-FDG Versus 68Ga-FAPI-46 as PET Tracer in ER-positive Breast Cancer.

Condition: Breast Cancer · Breast Neoplasms · Breast Diseases  ·  Sponsor: Maastricht University Medical Center

PhasePhase 2
Planned participants20
Who can joinFemale, 18 Years to no upper limit
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Thiemo JA van Nijnatten, MD, PhD  ·  +31433876910  ·  thiemo.nijnatten@mumc.nl

Lisa EHW Duijx, MSc  ·  +31639289798  ·  lisa.duijx@mumc.nl

Always discuss trial participation with your own doctor first.

Locations (1)

Maastricht University Medical Center+Maastricht, NetherlandsRecruiting

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Source record: clinicaltrials.gov/study/NCT06335069