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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00484614 on ClinicalTrials.gov