Breast Cancer
Conditions
Keywords
PET, PEM, Positron Emission Mammography, Breast Biopsy
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.
Interventions
PROCEDUREPEM Breast Biopsy
Breast biopsy using PEM guidance and Stereo Navigator software
Sponsors
University of Cincinnati
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility That Breast Biopsy Can be Performed Using PEM and Stereo Navigator Software After Diagnostic PEM on the Same Day. | At time of biopsy |
Countries
United States
Participant flow
Recruitment details
Recruited from 02/2010 to 06/2011 from University of Cincinnati Medical Center, Radiology Department, Breast Imaging.
Participants by arm
| Arm | Count |
|---|---|
| Primary Women 25 years or older with a highly suspicious finding for possible breast cancer on mammography and/or ultrasound, who are to be scheduled for percutaneous breast biopsy. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | Primary |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants |
| Sex: Female, Male Female | 20 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lesions Visualized Using Positron Emission Mammography (PEM) | Feasibility That Breast Biopsy Can be Performed Using PEM and Stereo Navigator Software After Diagnostic PEM on the Same Day. | Index Lesioins | 22 Breast Lesions |
| Lesions Visualized Using Positron Emission Mammography (PEM) | Feasibility That Breast Biopsy Can be Performed Using PEM and Stereo Navigator Software After Diagnostic PEM on the Same Day. | Index Lesions Visualized at PEM | 21 Breast Lesions |
| Lesions Visualized Using Positron Emission Mammography (PEM) | Feasibility That Breast Biopsy Can be Performed Using PEM and Stereo Navigator Software After Diagnostic PEM on the Same Day. | Additional Lesions seen only at PEM | 6 Breast Lesions |
| Lesions Visualized Using Positron Emission Mammography (PEM) | Feasibility That Breast Biopsy Can be Performed Using PEM and Stereo Navigator Software After Diagnostic PEM on the Same Day. | Lesions technically adequate for targeting | 26 Breast Lesions |
| Lesions Visualized Using Positron Emission Mammography (PEM) | Feasibility That Breast Biopsy Can be Performed Using PEM and Stereo Navigator Software After Diagnostic PEM on the Same Day. | Number of Lesions Biopsied | 24 Breast Lesions |