Breast Cancer Clinical Trial
Official title:
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
The overall goal of this study is to determine how FDG-PET can be incorporated into the
assessment of the axilla in the staging and treatment of women with early stage breast
cancer.
A multicentre, prospective, diagnostic accuracy study will be conducted evaluating the
ability of positronic emission tomography using fluorodeoxyglucose (FDG-PET) to detect the
presence or absence of axillary lymph node metastases in newly diagnosed breast cancer
patients with no clinical evidence of spread of disease beyond the breast.
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
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