Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00201942
Status:
COMPLETED
Last Update Posted:
2007-10-18
First Post:
2005-09-13
Brief Title:
PET Imaging to Determine the Role of PET in the Assessment of Regional Disease in Breast Cancer PET PREDICT Trial
Sponsor:
Ontario Clinical Oncology Group OCOG
Organization:
Ontario Clinical Oncology Group OCOG
Study Overview
Official Title:
A Prospective Study to Determine the Role of 2-18FFluoro-2-Deoxy-D-Glucose FDGPositron Emission Tomography PETin the Assessment of Regional Nodal Spread of Disease in Breast Cancer Patients
Status:
COMPLETED
Status Verified Date:
2007-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None