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

Completed · Not applicable

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT00981812

Run by

University of Cincinnati

People needed

20

Starts

2009-09-01

Expected to finish

2012-04-01

Last updated by the study team

2016-04-04

Who can join

Age: 25 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• UC Hospital, The Barrett Center — Cincinnnati, Ohio, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.