Imaging of In Vivo Sigma-2 Receptor Expression With [18F]ISO-1 Positron Emission Tomography (PET/CT) in Primary Breast Cancer

Inclusion Criteria:

- 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). 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. The
investigators 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.