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Positron Emission Mammography (PEM) Flex Solo II Positron Emission Tomography (PET) Scanner and Stereo Navigator Biopsy Accessory for the Diagnosis of Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by University of Cincinnati.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Mary Mahoney, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00981812
First received: September 18, 2009
Last updated: March 2, 2012
Last verified: March 2012

September 18, 2009
March 2, 2012
September 2009
December 2011   (final data collection date for primary outcome measure)
Evidence that breast biopsy can be performed using PEM and Stereo Navigator software [ Time Frame: At time of biopsy ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00981812 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Positron Emission Mammography (PEM) Flex Solo II Positron Emission Tomography (PET) Scanner and Stereo Navigator 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
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.
 
Recruiting
25
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
No
Contact: Monene M Kamm, AS 513-584-2916 kammmm@ucmail.uc.edu
United States
 
NCT00981812
Cincinnati-01
No
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 2012

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