Imaging of Primary or Recurrent Breast Cancer With 18F-FluorThanatrace PET/CT

Patients who come to the clinical practices of the University of Pennsylvania for diagnosis
and/or treatment of a known or suspected breast cancer and who meet the study inclusion
criteria may be approached by study staff for recruitment into this study. Eligibility
criteria will be checked and study personnel will provide a copy of the approved consent form
to the potential subject. Patients will be approached initially in person, by phone or email
about study participation. The patient will be given an opportunity to go over the consent
form and have any questions answered by study staff or a study investigator. After discussion
of the study procedures, risks and benefits, if the subject agrees to participate in the
study, the [18F]FTT PET/CT will be ordered by a physician and scheduled. Subjects may cancel
the scan appointment at any time prior to the injection of [18F]FTT with no negative impact
to them or their medical care at UPenn. A written informed consent will be reviewed with the
subject and signed prior to any study procedures being performed. Subjects may withdraw from
the study at any time at their own request, or they may be withdrawn at any time at the
discretion of the investigator or sponsor for safety, behavioral, or administrative reasons.
If a subject does not return for a scheduled visit, every effort will be made to contact the
subject.

Women of childbearing potential will have a urine pregnancy test performed within 1 day prior
to injection of [18F]FTT.

The baseline [18F]FTT PET/CT will take place prior to surgical resection of a primary breast
cancer, or before starting therapy. Adverse event follow up after the PET/CT scan may occur
by telephone or in person, depending on the subject's schedule. Follow up will take place the
next available business day (i.e. not a weekend or a holiday). The adverse event monitoring
period is 24 hours following [18F]FTT injection.

An optional post-therapy [18F]FTT PET/CT may occur approximately 1 day to 3 weeks after the
start of new therapy regimen.

Subjects will be asked to give consent to allow for collection of pathology tissue for use in
this research study. Archival tissue may be collected from an existing tissue sample.
Additional tissue may be collected during a clinical biopsy or surgical procedure, if a
procedure is scheduled as part of their clinical care or, it can be collected for research
purposes only, if the patient has consented for this additional collection.

Patients will be asked permission to access their medical records for follow up of their
clinical care and treatment as part of the consent for this study.

Long term follow up will occur by medical record review for the duration of the subject's
cancer care until death or 15 years after enrollment.

Inclusion Criteria:

1. Participants will be ≥ 18 years of age

2. Known or suspected, in the opinion of an investigator, primary breast or metastatic
breast cancer. For subjects with primary breast cancer we will target lesion size of
1.0 cm or greater on at least one type of standard imaging.

3. Participants must be informed of the investigational nature of this study and be
willing to provide written informed consent and participate in this study in
accordance with institutional and federal guidelines prior to study-specific
procedures.

Exclusion Criteria:

1. Females who are pregnant or breast feeding at the time of enrollment will not be
eligible for this study; a urine pregnancy test will be performed in women of
child-bearing potential prior to FTT injection.

2. Inability to tolerate imaging procedures in the opinion of an investigator or treating
physician

3. Any current medical condition, illness, or disorder as assessed by medical record
review and/or self-reported that is considered by a physician investigator to be a
condition that could compromise participant safety or successful participation in the
study