Imaging the Patterns of Breast Cancer Early Metastases
Condition: Breast Cancer
MeSH terms: Breast Neoplasms; Neoplasm Metastasis
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Positron emission tomography/x-ray computed tomography; Magnetic resonance imaging; x-ray computed tomography (CT)
Intervention type(s): Device; Device; Device
Intervention description(s): A whole-body PET/CT will be performed to identify the site and extent of spread.; A brain MRI will be performed.; A CT scan will be performed to identify the site and extent of spread.
Other intervention name(s): PET/CT; MRI; CT
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: metastasis; 3D imaging; early detection