Study the Role of Positron Emission Mammography in Pre-surgical Planning for Breast Cancer
NCT00484614 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 472
Last updated 2009-09-03
Summary
Women with newly diagnosed breast cancer anticipating breast-conserving surgery are enrolled into the study and will undergo both high-resolution positron emission mammographic (PEM) imaging and contrast-enhanced magnetic resonance imaging (MRI) of the breast(s). The purpose of this study is to determine changes in surgical management resulting from PEM or MRI imaging as compared to conventional imaging and to determine if the changes were appropriate with histopathology as gold standard.
Conditions
Interventions
- PROCEDURE
-
Positron Emission Mammography
Molecular Imaging Device
- PROCEDURE
-
Magnetic Resonance Imaging
Imaging Device
Sponsors & Collaborators
-
Certus International, Inc.
collaborator OTHER -
Naviscan PET Systems
lead INDUSTRY
Principal Investigators
-
Wendie A Berg, MD, Ph.D · American Radiology Services, Johns Hopkins Greenspring, Lutherville, MD
-
Etta Pisano, MD, FACR · University of North Carolina School of Medicine, Chapel Hill, NC
-
Kathy Schilling, MD · Boca Raton Community Hospital, Boca Raton, FL
-
Marie Tartar, MD · Scripps Cancer Center, San Diego, CA
-
Linda Hovanessian Larsen, MD · USC Norris Cancer Center
-
Lorraine Tafra, MD · Anne Arundel Medical Center, MD
Study Design
- Allocation
- RANDOMIZED
- Purpose
- DIAGNOSTIC
- Masking
- SINGLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 25 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-09-30
- Primary Completion
- 2008-11-30
- Completion
- 2009-03-31
Countries
- United States
Study Locations
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