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

Breast Cancer research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Breast Cancer

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Procedure:PEM Breast BiopsyBreast biopsy using PEM guidance and Stereo Navigator software

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

PEM Breast BiopsyAll patients underwent PEM biopsy.

Study Status

Completed

Start Date: September 2009

Completed Date: April 2012

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Feasibility That Breast Biopsy Can be Performed Using PEM and Stereo Navigator Software After Diagnostic PEM on the Same Day.

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Mary C Mahoney, MD

Lead Sponsor: University of Cincinnati

Collaborator:

More information:https://clinicaltrials.gov/show/NCT00981812

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