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Sponsors and Collaborators: |
Ontario Clinical Oncology Group (OCOG) Ontario Ministry of Health and Long Term Care |
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Information provided by: | Ontario Clinical Oncology Group (OCOG) |
ClinicalTrials.gov Identifier: | NCT00201942 |
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.
Condition | Intervention | Phase |
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Breast Cancer |
Procedure: PET scan |
Phase III |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
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 |
Enrollment: | 336 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, Ontario | |
Juravinski Cancer Centre | |
Hamilton, Ontario, Canada, L8V 1C3 | |
Sunnybrook Regional Cancer Centre and Women's College | |
Toronto, Ontario, Canada, M4N 3M5 | |
Ottawa Regional Cancer Centre | |
Ottawa, Ontario, Canada, K1Y 4K7 | |
London Regional Cancer Centre | |
London, Ontario, Canada, N6A 4L6 | |
Princess Margaret Hospital | |
Toronto, Ontario, Canada, M5G 2M9 | |
St. Michael's | |
Toronto, Ontario, Canada, M5B 1W8 | |
Kingston Regional Cancer Centre | |
Kingston, Ontario, Canada, K7L 5P9 | |
North York | |
Toronto, Ontario, Canada, M2J 1V1 | |
Mount Sinai Hospital | |
Toronto, Ontario, Canada, M5G 1X5 | |
St. Joseph's | |
Hamilton, Ontario, Canada, L8N 4A6 |
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 |
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 |
Study ID Numbers: | CTA-Control-092493 |
Study First Received: | September 13, 2005 |
Last Updated: | October 17, 2007 |
ClinicalTrials.gov Identifier: | NCT00201942 |
Health Authority: | Canada: Health Canada |
Breast Cancer Diagnosis PET Positronic Emission Tomography fluorodeoxyglucose |
Skin Diseases Deoxyglucose Breast Neoplasms Breast Diseases |
Neoplasms Neoplasms by Site |