An Early Phase Clinical Trial to Evaluate the Feasibility of CEST MRI in Patients With Early Stage Breast Cancer

Those involved in the treatment of patients with breast cancer have pioneered the field of
personalized cancer therapy through the use of targeted therapies and their associated
biomarkers. Assays to quantify tumor acidosis and hypoxia are hypothesized to potentially
represent such biomarkers. However there is currently no gold standard for measuring either.

This trial will evaluate the feasibility of translating preclinical Chemical Exchange
Saturation Transfer (CEST) MRI protocol designed to estimate tumor extracellular pH (pHe),
to a clinical MRI scanner in women with early stage breast cancer. This trial will generate
preliminary data regarding the feasibility of this imaging technique. If successful, in
future studies CEST MRI may serve as an imaging biomarker for acidosis and hypoxia.

Inclusion Criteria:

- Newly diagnosed infiltrating ductal carcinoma (IDC) of the breast

- >= 1.0 cm primary tumor

- Calculated creatinine clearance >= 50 mL/min

- Willing and able to provide informed consent

- Age ≥ 18 years

- ECOG performance status 0-2

- Informed of the investigational nature of this study

Exclusion Criteria:

- Allergy to iodinated contrast agent

- Use of metformin, aminoglycosides, other nephrotoxic medications, or daily use of
NSAIDs

- Diabetes mellitus

- History of severe claustrophobia

- Presence of electrically, magnetically, or mechanically activated implants including
cardiac pacemakers, cochlear implants, magnetic surgical clips or prosthesis that
would preclude MRI

- Use of > 1 antihypertensive drug

- Pregnancy or breastfeeding

- Paraproteinemia syndromes or multiple myeloma

- Collagen vascular disease

- Active hyperthyroidism

- Active pharmaceutical treatments for cancer