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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMaastricht University Medical Center

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

Age <18

Pregnancy

Patients with secondary malignancies (except non-melanoma skin cancer)

No 18F-FDG PET/CT or 18F-FDG PET/MRI scan.

Trial design

Treatments tested in this trial

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

Treatment groups

20 Participants
are divided into 1 treatment group