A Prospective Study to Determine the Role of 2-[18F]Fluoro-2-Deoxy-D-Glucose (FDG)Positron Emission Tomography (PET)in the Assessment of Regional Nodal Spread of Disease in Breast Cancer Patients
Patients will have histologic confirmation of invasive breast cancer and will have a FDG-PET
scan prior to axillary node assessment. All patients will have a sentinel node biopsy if
any sentinel nodes can be located. Patients with a positive sentinel node will have an
axillary node dissection. The results of the PET will be compared to the reference standard
of histologic examination of all excised (sentinel and non-sentinel) axillary lymph nodes
which will be referred to as axillary node assessment. Sensitivity, specificity, positive
and negative predictive values for PET-FDG will be determined.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
The primary outcomes are the sensitivity and specificity of FDG-PET in axillary node assessments using axillary node assessment [Sentinel Node Biopsy(SNB) with or without Axillary Node Dissection (AND)] as the reference standard.
Kathleen Pritchard, MD
Sunnybrook Regional Cancer Centre
Canada: Health Canada