Positron Emission Mammography (PEM) Biopsy Accessory for the Diagnosis of Breast Cancer

University of Cincinnati

Status

Completed

Conditions

Breast Cancer

Treatments

Procedure: PEM Breast Biopsy

Study type

Interventional

Funder types

Other

Identifiers

NCT00981812

Cincinnati-01

Details and patient eligibility

About

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.

Full description

See brief summary.

Enrollment

20 patients

Sex

Female

Ages

25+ years old

Volunteers

No Healthy Volunteers

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