Fluorine F 18 ISO-1 PET/CT Imaging in Detecting Sigma-2 Receptor in Patients with Known or Suspected Breast Cancer

Inclusion Criteria

• 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 magnetic resonance imaging [MRI]); only one type of imaging is required to show a lesion of 1 cm or greater in order for the patient to be eligible to participate in this study; patients that have a prior diagnosis of primary breast cancer in the opposite breast can be included
• 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 procedures, 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; only individuals (aged 18 or over) who can understand and give informed consent will be approached to participate in this study; individuals who are considered to be mentally disabled will not be recruited for this study; all subjects must understand and be able to give informed consent; we will not be using specific methods to assess decisional capacity; economically disadvantaged persons will not be vulnerable to undue influence, as this study offers no compensation; all individuals will be told that their choice regarding study participation will in no way change their access to clinical care; this should negate any undue influence or coercion; children, fetuses, neonates, or prisoners are not included in this research study; the menopausal status of the study participant will be reviewed during the screening process by examining the patient’s chart, women of childbearing potential will have a serum or urine pregnancy test at the time of screening