PET Imaging to Determine the Role of PET in the Assessment of Regional Disease in Breast Cancer (PET PREDICT Trial)
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|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 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.
- Patients with positive FDG-PET in non-axillary nodal areas;
- Patients with positive FDG-PET in other non-nodal areas;
- Patients with positive FDG-PET in the residual breast tissue.
|Study Start Date:||February 2005|
|Study Completion Date:||May 2007|
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.
|Juravinski Cancer Centre|
|Hamilton, Ontario, Canada, L8V 1C3|
|Hamilton, Ontario, Canada, L8N 4A6|
|Kingston Regional Cancer Centre|
|Kingston, Ontario, Canada, K7L 5P9|
|London Regional Cancer Centre|
|London, Ontario, Canada, N6A 4L6|
|Ottawa Regional Cancer Centre|
|Ottawa, Ontario, Canada, K1Y 4K7|
|Sunnybrook Regional Cancer Centre and Women's College|
|Toronto, Ontario, Canada, M4N 3M5|
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Toronto, Ontario, Canada, M2J 1V1|
|Mount Sinai Hospital|
|Toronto, Ontario, Canada, M5G 1X5|
|Toronto, Ontario, Canada, M5B 1W8|
|Study Chair:||Kathleen Pritchard, MD||Sunnybrook Regional Cancer Centre|
|Principal Investigator:||Claire Holloway, MD||Sunnybrook Regional Cancer Centre|
|Principal Investigator:||David McCready, MD||Princess Margaret Hospital, Canada|
|Principal Investigator:||Jim Julian, M.Math.||McMaster University|
|Principal Investigator:||Mark N Levine, MD||Ontario Clinical Oncology Group (OCOG)|
|Principal Investigator:||Wendy Shelley, MD||Kingston Regional Cancer Centre|
|Principal Investigator:||Karen Gulenchyn, MD, PhD||McMaster University|
|Principal Investigator:||Frances O'Malley, MD||Mount Sinai Hospital, New York|