Status:
COMPLETED
Pre-Surgery Positron Emission Mammography in Patients With Newly Diagnosed Breast Cancer
Lead Sponsor:
Swedish Medical Center
Conditions:
Breast Cancer
Breast Cancer Surgery
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of the study is to determine the optimal, lowest dose of radioactive tracer required for Positron Emission Mammography (PEM), and the accuracy and reliability of PEM in pre-surgical evalua...
Detailed Description
The purpose of this research in Phase 1 is to determine the lowest dose of radionuclide 18F-FDG that can be used in the Diagnostic use of Positron Emission Mammography for the diagnosis of multifocal ...
Eligibility Criteria
Inclusion
- Must be 18 years of age or older
- Newly diagnosed primary breast cancer
- Must have a breast or breast/chest MRI ordered as part of standard of care
- Must meet one or more of the following in Part 1:
- T1 carcinoma of the breast appropriate for breast conserving surgery diagnosis established by core biopsy
- Tis (ductal carcinoma in situ) carcinoma \> 2 cm diameter
- Invasive lobular carcinoma of the breast
- Must meet the following in Part 2:
- Known invasive or in situ primary breast cancer identified on pre-surgical breast MRI to have an unsuspected 2nd lesion recommended for biopsy and biopsy has not yet been performed
Exclusion
- Known diabetes mellitus
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT01241721
Start Date
September 1 2010
End Date
April 1 2016
Last Update
November 18 2016
Active Locations (2)
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1
Swedish Cancer Institute
Seattle, Washington, United States, 98104
2
Swedish Cancer Institute Cherry Hill Campus - Comprehensive Breast Center
Seattle, Washington, United States, 98122