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

This study has been completed.
Information provided by (Responsible Party):
Mary Mahoney, University of Cincinnati Identifier:
First received: September 18, 2009
Last updated: March 3, 2016
Last verified: March 2016
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.

Condition Intervention
Breast Cancer
Procedure: PEM Breast Biopsy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Clinical Utility and Initial Experience With PEM Flex Solo II PET Scanner and Stereo Navigator Biopsy Accessory for the Diagnosis of Breast Cancer

Resource links provided by NLM:

Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • 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 ]

Enrollment: 20
Study Start Date: September 2009
Study Completion Date: April 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PEM Breast Biopsy
All patients underwent PEM biopsy.
Procedure: PEM Breast Biopsy
Breast biopsy using PEM guidance and Stereo Navigator software
Other Names:
  • Naviscan PEM 2400 Pet Scanner
  • Stereo Navigator Accessory

Detailed Description:
See brief summary.

Ages Eligible for Study:   25 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00981812

United States, Ohio
UC Hospital, The Barrett Center
Cincinnnati, Ohio, United States, 45219
Sponsors and Collaborators
University of Cincinnati
Principal Investigator: Mary C Mahoney, MD Univeristy of Cincinnati
Principal Investigator: Amy Argus, MD University of Cincinnati
  More Information

Responsible Party: Mary Mahoney, Professor, Director of Breast Imaging, University of Cincinnati Identifier: NCT00981812     History of Changes
Other Study ID Numbers: Cincinnati-01
Study First Received: September 18, 2009
Results First Received: December 23, 2014
Last Updated: March 3, 2016

Keywords provided by University of Cincinnati:
Positron Emission Mammography
Breast Biopsy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases processed this record on April 24, 2017