Imaging the Patterns of Breast Cancer Early Metastases

Status:	Active, not recruiting
Conditions:	Breast Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	18 - 110
Updated:	3/16/2019
Start Date:	April 2016
End Date:	March 2021

Currently, once a distant breast metastasis has been diagnosed, 65% of patients will succumb
to their cancer within 2 years, and 80% will succumb by 5 years. The current National
Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Breast Cancer do not
recommend surveillance imaging for earlier detection of distant metastases, even for
high-risk breast cancer patients. Whereas, the standard-of-care treatment of the small
isolated (few in number) breast cancer metastases is to perform surgical resection or locally
ablative radiation therapy, however, the follow-up of breast cancer patients (including those
with a >= 30% risk of developing metastases) is to wait for clinical symptoms to appear
before using a dual positron emission tomography (PET) and diagnostic quality computed
tomography (CT) PET/CT scan, magnetic resonance imaging (MRI), computed tomography (CT) or a
bone scan to identify the site and extent of spread. Unfortunately, once metastases become
symptomatic they are often too large and/or numerous to treat with curative intent. The
current national care guidelines that advocate against intensive surveillance for distant
metastases are based on two studies performed in Italy from 1985-1993 that concluded that the
available imaging and treatment tools of the day did not prolong 5-year survival. Since then,
however, there have been major improvements in imaging and treatment technology. To be
treatable the metastases must be limited in number and limited in size, typically 6 or fewer
metastases, each of size 5 centimeter or less. This state of metastatic presentation is
called oligometastases. Numerous pilot studies have achieved dramatically improved overall
and disease-free survival when oligometastases are treated using a combined systemic plus
locally-ablative therapy of each oligometastasis. A scientific concern with the
aforementioned research studies involving ablation of isolated oligometastases, was that they
were not carried out with consistent use of surveillance imaging. Instead, these studies
effectively preselected patients for enrollment based upon having an existing oligometastatic
presentation. 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.

All enrolled subjects will undergo a single whole-body dual positron emission tomography
(PET) and diagnostic quality computed tomography (CT) PET/CT scan and a 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. In addition, the
medical records related to the breast cancer and care, obtained and maintained as per
standard-of-care, will be monitored for up to 5 years.

In this research study the investigators will acquire a PET/CT image of the body (neck to
mid-thigh) using best-practice diagnostic imaging protocols, typically involving 64-slice CT
systems, 1x1x3 mm voxel dimensions, use of non-ionic contrast agents, and breath-holding for
motion correction. Subjects will also receive a single MRI with injected contrast of the
brain using best-practice diagnostic imaging protocols, typically involving a 3-Tesla
clinical MRI system.

Inclusion Criteria:

- Female patients with breast cancer who have completed radiation therapy 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:

- 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.

- Pregnant women are excluded because of possible radiation risk to the fetus.

We found this trial at

sites

Department of Radiation Oncology Davis Cancer Pavilion

Gainesville, Florida 32611

Principal Investigator: Walter O'Dell, PhD

Phone: 352-265-0680

from

Gainesville, FL