Status:
COMPLETED
Positron Emission Mammography (PEM) Biopsy Accessory for the Diagnosis of Breast Cancer
Lead Sponsor:
University of Cincinnati
Conditions:
Breast Cancer
Eligibility:
FEMALE
25+ years
Phase:
NA
Brief Summary
The purpose of this research study is to evaluate how well the Stereo Navigator Biopsy Accessory for the PEM Flex solo II PET Scanner works for performing breast biopsy on suspicious lesions. This stu...
Detailed Description
See brief summary.
Eligibility Criteria
Inclusion
- female
- subject is 25-100 years of age
- subjects has at least one breast imaging finding on mammography and/or ultrasound which is assessed as highly suggestive of malignancy and recommended to biopsy
- subject is able to provide informed consent
Exclusion
- subject is pregnant
- subject is actively lactating or discontinued breastfeeding less than 2 months ago
- subject has breast implants
- subject is scheduled for sentinel node procedure using radioactive Tc-99m within 24 hours of the PEM study
- subject has contraindications for core biopsy and other invasive procedures
- subject has Type I diabetes mellitus or poorly controlled Type II diabetes mellitus
- subject has had surgery or radiation therapy on the study breast or has had chemotherapy within the past 12 months
- subject has not fasted for 4-6 hours prior to the procedure and/or have a fasting blood glucose level greater than 140 mg/dl on day of PEM imaging
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00981812
Start Date
September 1 2009
End Date
April 1 2012
Last Update
April 4 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UC Hospital, The Barrett Center
Cincinnnati, Ohio, United States, 45219