Positron Emission Mammography (PEM) Biopsy Accessory for the Diagnosis of Breast Cancer
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 25 - Any |
| Updated: | 4/21/2016 |
| Start Date: | September 2009 |
| End Date: | April 2012 |
Clinical Utility and Initial Experience With PEM Flex Solo II PET Scanner and Stereo Navigator Biopsy Accessory for the Diagnosis of Breast Cancer
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.
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.
See brief summary.
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
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