Positron Emission Mammography (PEM) Biopsy Accessory for the Diagnosis of Breast Cancer
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PEM Breast Biopsy
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Cancer focused on measuring PET, PEM, Positron Emission Mammography, Breast Biopsy
Eligibility 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
Sites / Locations
- UC Hospital, The Barrett Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PEM Breast Biopsy
Arm Description
All patients underwent PEM biopsy.
Outcomes
Primary Outcome Measures
Feasibility That Breast Biopsy Can be Performed Using PEM and Stereo Navigator Software After Diagnostic PEM on the Same Day.
Secondary Outcome Measures
Full Information
NCT ID
NCT00981812
First Posted
September 18, 2009
Last Updated
March 3, 2016
Sponsor
University of Cincinnati
1. Study Identification
Unique Protocol Identification Number
NCT00981812
Brief Title
Positron Emission Mammography (PEM) Biopsy Accessory for the Diagnosis of Breast Cancer
Official Title
Clinical Utility and Initial Experience With PEM Flex Solo II PET Scanner and Stereo Navigator Biopsy Accessory for the Diagnosis of Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
April 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cincinnati
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
PET, PEM, Positron Emission Mammography, Breast Biopsy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PEM Breast Biopsy
Arm Type
Experimental
Arm Description
All patients underwent PEM biopsy.
Intervention Type
Procedure
Intervention Name(s)
PEM Breast Biopsy
Other Intervention Name(s)
Naviscan PEM 2400 Pet Scanner, Stereo Navigator Accessory
Intervention Description
Breast biopsy using PEM guidance and Stereo Navigator software
Primary Outcome Measure Information:
Title
Feasibility That Breast Biopsy Can be Performed Using PEM and Stereo Navigator Software After Diagnostic PEM on the Same Day.
Time Frame
At time of biopsy
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary C Mahoney, MD
Organizational Affiliation
Univeristy of Cincinnati
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Amy Argus, MD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Hospital, The Barrett Center
City
Cincinnnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Positron Emission Mammography (PEM) Biopsy Accessory for the Diagnosis of Breast Cancer
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