Protocol Summary

Protocol No.: 14548

Sponsor Protocol No.: 201500683

Study Title
Imaging the Patterns of Breast Cancer Early Metastases

Principal Investigator(s)
O'Dell, Walter

Objective
The primary objectives of the research study are to: (1) determine the feasibility of the stated interventions in a multi-institutional setting; (2) document the patterns of early metastatic spread of breast cancer; (3) document the proportion of high-risk breast cancer patients that have an oligometastatic presentation within this proactive imaging protocol, and (4) provide a basis to determine how to optimize future surveillance imaging protocols with respect to the time to progression, rate of tumor growth and organs that are affected.

Description
All enrolled subjects will undergo a single whole-body Positron emission tomography/x-ray computed tomography (PET/CT) scan and a diagnostic-quality x-ray computed tomography (CT) scan with contrast acquired in the same imaging session; and a single brain magnetic resonance imaging (MRI) scan with contrast to be completed in separate imaging session but within 2 weeks of the PET/CT scan. Imaging will take place within 7 months after enrollment.

UF clinical trials site for this study http://oncore.cancer.ufl.edu/sip/SIPControlServlet?hdn_function=SIP_PROTOCOL_SUMMARY&protocol_no=201500683

Phase: NA

Age Group: Adult

Scope: National

Treatment
There is no treatment in this study.

Detailed Eligibility
INCLUSION CRITERIA:
1. Ages 18 years old and older
2. Female patients with breast cancer who have presented within the last 48 months with a diagnosis that associates them with high risk (>30%) for developing metastatic disease but who at the time of enrollment are not known to have metastatic disease. Patients meeting this criterion are those that have either of the following presentations:
- hormone receptor (or triple) negative breast cancer with 3 or more positive axillary lymph nodes;
- a Stage III diagnosis;
- a primary tumor >2 cm and positive axillary lymph nodes;
- multiple primary tumors with cumulative volume >= that of a single 2 centimeter tumor, and positive axillary lymph nodes
- any number of lymph nodes with extranodal extension;
- any internal mammary or supraclavicular nodes;
- any primary tumor that has grown into the chest wall or skin;
- or inflammatory breast cancer.

EXCLUSION CRITERIA:
1. Patients not willing to submit to a PET/CT scan and a brain MRI scan with injected vascular contrast at the Department of Radiology at University of Florida or University of Miami.
2. Pregnant women are excluded because of possible radiation risk to the fetus.

Applicable Disease Sites
Breast Cancer

Participating Institutions
UF Gainesville
UF Jacksonville

Contact
John Lybarger, MPH, CCRC
Phone: 352-265-0680
Phone Extension: 87829
Email: lybarj@shands.ufl.edu