Hybrid Molecular Imaging of ER in Breast Cancer Patients With DCIS

Integrated whole-body magnetic resonance imaging (MRI)-positron emission tomography (PET)
scanners have recently been introduced for clinical use. This technology combines the
anatomic and perfusion data obtained with Dynamic Contrast Enhanced (DCE) MRI with functional
imaging data obtained from PET. For breast imaging, the combination of MRI and PET has
important potential to improve diagnostic accuracy and provide molecular characterization of
breast cancer. The overall purpose of this research is to assess the analytic validity of
simultaneous breast DCE MRI with 18F-FES PET for measuring estrogen receptor (ER) in patients
with ductal carcinoma in situ (DCIS) and identifying patients with low-risk of disease
recurrence. We hypothesize that quantitative 18F-FES uptake parameters from PET/MRI will
correlate well with the ER immunohistochemistry score and with low-risk recurrence scores.

Primary Objective

1) To compare quantitative 18F-FES uptake of biopsy-proven DCIS measured using PET/MRI with
ER protein levels determined by immunohistochemistry.

Secondary Objectives

1. To determine the optimal cut-point 18F-FES uptake value for distinguishing between ER+
and ER-negative DCIS

2. To determine the test-retest reproducibility of quantitative assessment of tumor 18F-FES
uptake

3. To determine the optimal cut-point 18F-FES uptake value for distinguishing between
low-risk DCIS and intermediate/high-risk DCIS

4. To estimate the association of quantitative 18F-FES uptake (continuous SUVmax) with
research-based Oncotype DX DCIS scores (0-100)

5. To measure the upgrade rate to invasive cancer at surgical excision

6. To correlate tumor 18F-FES uptake with serum estradiol and sex hormone binding globulin
levels.

Inclusion Criteria:

- Diagnosis of biopsy-proven DCIS without invasion or microinvasion measuring at least
1.5 cm in diameter by any imaging modality

- Undergoing diagnostic breast MRI ordered by the referring clinician for staging and
extent of disease

Exclusion Criteria:

- Inability or unwillingness to provide informed consent to the study

- Surgery, radiation, neoadjuvant chemo/endocrine therapy for the current malignancy
prior to study enrollment

- Patients currently taking or have taken an ER-blocking medication (e.g. tamoxifen,
raloxifene) within 6 weeks prior to study enrollment

- Pregnant or lactating women

- Patient with intolerance or contraindications for MRI or gadolinium-based contrast
agents

- Patient girth exceeds the bore of the MRI/PET scanner

- Patients requiring conscious sedation for imaging

- Patients with a history of allergic reaction attributable to compounds of similar
chemical or biologic composition to 18F-FES

- Patients in liver failure as judged by the patient's physician, due to the
hepatobiliary clearance of 18F-FES

- Patients requiring conscious sedation for imaging