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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

This study is currently recruiting participants.
Verified March 2012 by University of Cincinnati
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
History of Changes
  Purpose

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:

U.S. FDA Resources

Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • Evidence that breast biopsy can be performed using PEM and Stereo Navigator software [ Time Frame: At time of biopsy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 25
Study Start Date: September 2009
Estimated 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 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.

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00981812

Contacts
Contact: Monene M Kamm, AS 513-584-2916 kammmm@ucmail.uc.edu

Locations
United States, Ohio
UC Hospital, The Barrett Center Recruiting
Cincinnnati, Ohio, United States, 45219
Contact: Monene M Kamm, AS     513-584-2916     kammmm@ucmail.uc.edu    
Principal Investigator: Mary C Mahoney, MD            
Sub-Investigator: Amy Argus, MD            
Sponsors and Collaborators
University of Cincinnati
Investigators
Principal Investigator: Mary C Mahoney, MD Univeristy of Cincinnati
Principal Investigator: Amy Argus, MD University of Cincinnati
  More Information

No publications provided

Responsible Party: Mary Mahoney, Professor, Director of Breast Imaging, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00981812     History of Changes
Other Study ID Numbers: Cincinnati-01
Study First Received: September 18, 2009
Last Updated: March 2, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on June 18, 2013