Positron Emission Mammography (PEM) Flex Solo II Positron Emission Tomography (PET) Scanner and Stereo Navigator Biopsy Accessory for the Diagnosis of Breast Cancer
Conditions
Breast Cancer
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
PET, PEM, Positron Emission Mammography, Breast Biopsy
Study Type
Interventional
Study Phase
N/A
Study Design
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Intervention
Name: PEM Breast Biopsy
Type: Procedure
Overall Status
Recruiting
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 study will also allow the doctors to describe the features of PEM detected lesions and the results obtained using the PEM guided biopsy and will compare the time it took to complete a pre-operative work up using PEM versus MRI in patients with a suspicious breast lesion resulting in cancer.
Detailed Description
See brief summary.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 25 Years
Gender: Female
Criteria: Inclusion Criteria:

- 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 Criteria:

- 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
Location
UC Hospital, The Barrett Center
Cincinnnati, Ohio, United States
Status: Recruiting
Contact: Monene M Kamm, AS - 513-584-2916 - kammmm@ucmail.uc.edu
Start Date
September 2009
Completion Date
April 2012
Sponsors
University of Cincinnati
Source
University of Cincinnati
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page