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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00981812
Recruitment Status : Completed
First Posted : September 22, 2009
Results First Posted : April 4, 2016
Last Update Posted : April 4, 2016
Information provided by (Responsible Party):
Mary Mahoney, University of Cincinnati

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Procedure: PEM Breast Biopsy Not Applicable

Detailed Description:
See brief summary.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : September 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00981812

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

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Responsible Party: Mary Mahoney, Professor, Director of Breast Imaging, University of Cincinnati Identifier: NCT00981812     History of Changes
Other Study ID Numbers: Cincinnati-01
First Posted: September 22, 2009    Key Record Dates
Results First Posted: April 4, 2016
Last Update Posted: April 4, 2016
Last Verified: March 2016

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

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases