AI-Powered Research

- Clinical stage II/III or locoregional recurrent breast cancer (all
histological types) with ER+ and low grade according to Bloom Richardson
criteria (grade 1-2)
- Females aged 18 years or older at screening
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2
- Candidates for treatment with curative intent (patients are also allowed for
inclusion in the current study if they have undergone recent surgery (<6 weeks)
for current breast cancer and require staging because of unexpected stage III
disease)
- [18F]FDG PET/CT imaging should be performed for staging according to standard
of care (in case [18F]FDG PET/CT imaging has already been performed, patients
can be included <=21 days after this scan)
- Estimated glomerular filtration rate (eGFR) >=30 ml/min
- Written and signed informed consent

Exclusion Criteria

- History with another cancer within the last 5 years, except non-melanoma skin
cancer
- Undergoing treatment for current breast cancer such as (neo)adjuvant
chemotherapy, hormonal therapy (only in case of Tamoxifen), radiotherapy or
investigational drug therapy
- Pregnancy or lactating women
- Any medical, psychological or social condition that may interfere with the
subject*s safety and participation in the study, will lead to exclusion from
this study

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1) Percentage of patients with a correctly changed treatment plan according to<br /><br>information obtained with [18F]FES PET/CT compared to [18F]FDG PET/CT at<br /><br>staging.<br /><br>2) Percentage of metastatic lesions detected with [18F]FES PET/CT compared to<br /><br>[18F]FDG PET/CT at staging.<br /><br>3) Percentage of missed metastases with [18F]FES PET/CT compared to [18F]FDG<br /><br>PET/CT (at staging and developed during follow-up).<br /><br>4) Percentage of correct treatment plans as well as diagnostic confidence after<br /><br>6 months of follow-up as determined by the adjudication committee based on the<br /><br>added information obtained with [18F]FES PET/CT compared to [18F]FDG PET/CT. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1) The relationship between the level of [18F]FES/[18F]FDG uptake in the<br /><br>primary tumor, lymph node and distant metastases and standard (size, location<br /><br>of lesion, histological subtype, grade, ER/PR/HER2 expression levels,<br /><br>Ki67%/mitotic index)/experimental clinicopathological parameters (intensity of<br /><br>ER staining, tumor cell and microvessel density, infiltration of lymphocytes,<br /><br>amount of necrosis and stroma, expression of glucose<br /><br>transporter-1 (GLUT1) of the primary tumor, lymph node and distant metastases).<br /><br>2) Cut off value for [18F]FDG SUV (max and peak) below which [18F]FES PET/CT<br /><br>adds information for staging.<br /><br>3) Cut off value for grade and ER expression level below which or above which,<br /><br>respectively, [18F]FES PET/CT adds information for staging.</p><br>