Status:
COMPLETED
PET Imaging to Determine the Role of PET in the Assessment of Regional Disease in Breast Cancer (PET PREDICT Trial)
Lead Sponsor:
Ontario Clinical Oncology Group (OCOG)
Collaborating Sponsors:
Ontario Ministry of Health and Long Term Care
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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, p...
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...
Eligibility Criteria
Inclusion
- Histologic diagnosis of invasive breast cancer,
- Resectable primary cancer.
Exclusion
- The diagnosis of invasive breast cancer was made more than 3 months prior to registration,
- Patient and/or surgeon are not willing to proceed with a SNB or AND after the PET scan is completed,
- Patient and/or surgeon are not willing to proceed with a level I and II AND if the SNB is positive, if the PET scan shows increased uptake in the ipsilateral axilla, or if the surgeon is still gaining experience in the performance of SNB,
- SNB or AND has already been done,
- Chemotherapy has been given or will be given prior to PET scan or SNB or AND,
- Significant serious concurrent medical problems (e.g., uncontrolled diabetes),
- Patient is pregnant or lactating,
- Patient is unable to lie supine and with both arms above their heads for PET scan,
- Known hypersensitivity to FDG,
- Clinical evidence of regional nodal metastases (fixed, matted axillary nodes),
- Clinical evidence of distant metastases.
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2007
Estimated Enrollment :
336 Patients enrolled
Trial Details
Trial ID
NCT00201942
Start Date
February 1 2005
End Date
May 1 2007
Last Update
October 18 2007
Active Locations (10)
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1
St. Joseph's
Hamilton, Ontario, Canada, L8N 4A6
2
Juravinski Cancer Centre
Hamilton, Ontario, Canada, L8V 1C3
3
Kingston Regional Cancer Centre
Kingston, Ontario, Canada, K7L 5P9
4
London Regional Cancer Centre
London, Ontario, Canada, N6A 4L6