Spots Global Cancer Trial Database for PET Imaging to Determine the Role of PET in the Assessment of Regional Disease in Breast Cancer (PET PREDICT Trial)
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Trial Identification
Brief Title: PET Imaging to Determine the Role of PET in the Assessment of Regional Disease in Breast Cancer (PET PREDICT 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
Study ID: NCT00201942
Conditions
Interventions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
St. Joseph's, Hamilton, Ontario, Canada
Juravinski Cancer Centre, Hamilton, Ontario, Canada
Kingston Regional Cancer Centre, Kingston, Ontario, Canada
London Regional Cancer Centre, London, Ontario, Canada
Ottawa Regional Cancer Centre, Ottawa, Ontario, Canada
North York, Toronto, Ontario, Canada
Sunnybrook Regional Cancer Centre and Women's College, Toronto, Ontario, Canada
St. Michael's, Toronto, Ontario, Canada
Mount Sinai Hospital, Toronto, Ontario, Canada
Princess Margaret Hospital, Toronto, Ontario, Canada
Contact Details
Name: Kathleen Pritchard, MD
Affiliation: Sunnybrook Regional Cancer Centre
Role: STUDY_CHAIR
Name: Claire Holloway, MD
Affiliation: Sunnybrook Regional Cancer Centre
Role: PRINCIPAL_INVESTIGATOR
Name: David McCready, MD
Affiliation: Princess Margaret Hospital, Canada
Role: PRINCIPAL_INVESTIGATOR
Name: Jim Julian, M.Math.
Affiliation: McMaster University
Role: PRINCIPAL_INVESTIGATOR
Name: Mark N Levine, MD
Affiliation: Ontario Clinical Oncology Group (OCOG)
Role: PRINCIPAL_INVESTIGATOR
Name: Wendy Shelley, MD
Affiliation: Kingston Regional Cancer Centre
Role: PRINCIPAL_INVESTIGATOR
Name: Karen Gulenchyn, MD, PhD
Affiliation: McMaster University
Role: PRINCIPAL_INVESTIGATOR
Name: Frances O'Malley, MD
Affiliation: MOUNT SINAI HOSPITAL
Role: PRINCIPAL_INVESTIGATOR
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