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Digital Breast Tomosynthesis Versus Contrast Enhanced Magnetic Resonance Imaging (MRI) for Breast Cancer Staging

NCT01060085 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 51

Last updated 2017-02-23

No results posted yet for this study

Summary

The primary objective of this study is to compare the diagnostic accuracy of Digital Breast Tomosynthesis (DBT) versus that of Contrast Enhanced Magnetic Resonance Imaging (CEMRI) in determining the size of breast cancer preoperatively.

Secondary objectives include:

1. Comparing the operating characteristics of each combined imaging protocol with respect to the reference standard, i.e. histopathologic assessment, of additional non-index lesions.
2. Comparison of re-excision rates based on estimated disease extent from adjunctive CEMRI vs. adjunctive DBT.
3. Evaluation of patient satisfaction with regard to the adjunctive modality (DBT vs. CEMRI).

Conditions

Sponsors & Collaborators

  • Hologic, Inc.

    collaborator INDUSTRY

  • Dartmouth-Hitchcock Medical Center

    lead OTHER

Principal Investigators

  • Steven P Poplack, MD · Dartmouth-Hitchcock Medical Center

Eligibility

Min Age
30 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT01060085 on ClinicalTrials.gov