[18F]ISO-1 Positron Emission Tomography (PET/CT) in Primary Breast Cancer

This study will evaluate the feasibility of using [18F]ISO-1 PET/CT to image sigma-2 receptor binding in primary breast tumors and continue to evaluate the safety of the tracer in this patient population. [18F]ISO-1 uptake measures will be correlated with qualitative immunohistochemical staining for cell proliferation (Ki67). This is an observational study in that [18F]ISO-1 PET/CT will not be used to direct treatment decisions.

Inclusion criteria

• Adult patients, at least 18 years of age
• Known or suspected breast cancer with at least one breast lesion that is 1 cm or greater in size by standard imaging (e.g. mammography, ultrasound or breast MRI)
• Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures

Exclusion criteria

• Females who are pregnant at the time of screening will not be eligible for this study, urine or serum pregnancy test will be performed in women of child-bearing potential at the time of screening.
• Inability to tolerate imaging procedure in the opinion of an investigator or treating physician
• Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
• Unwilling or unable to provide informed consent.