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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mary Mahoney, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00981812
First received: September 18, 2009
Last updated: March 3, 2016
Last verified: March 2016

September 18, 2009
March 3, 2016
September 2009
December 2011   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Evidence that breast biopsy can be performed using PEM and Stereo Navigator software [ Time Frame: At time of biopsy ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00981812 on ClinicalTrials.gov Archive Site
Not Provided
Evidence that breast biopsy can be performed in less clinical visits than if biopsy is performed using MRI, mammogram, and/or ultrasound [ Time Frame: At time of final pathology diagnosis ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Positron Emission Mammography (PEM) Biopsy Accessory for the Diagnosis of Breast Cancer
Clinical Utility and Initial Experience With PEM Flex Solo II PET Scanner and Stereo Navigator Biopsy Accessory for the Diagnosis of Breast Cancer
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.
See brief summary.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Breast Cancer
Procedure: PEM Breast Biopsy
Breast biopsy using PEM guidance and Stereo Navigator software
Other Names:
  • Naviscan PEM 2400 Pet Scanner
  • Stereo Navigator Accessory
Experimental: PEM Breast Biopsy
All patients underwent PEM biopsy.
Intervention: Procedure: PEM Breast Biopsy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
April 2012
December 2011   (final data collection date for primary outcome measure)

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
Female
25 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00981812
Cincinnati-01
No
Not Provided
Not Provided
Mary Mahoney, University of Cincinnati
University of Cincinnati
Not Provided
Principal Investigator: Mary C Mahoney, MD Univeristy of Cincinnati
Principal Investigator: Amy Argus, MD University of Cincinnati
University of Cincinnati
March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP