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Cone Beam Computed Tomography for Breast Imaging

NCT01107860 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 401

Last updated 2013-06-18

No results posted yet for this study

Summary

The primary aim of this study is to continue the investigation of cone beam computed tomography (CBCT) for breast imaging already underway in the diagnostic setting by providing a compelling body of evidence incorporating non-contrast CBCT in the study protocol. The goal is to accumulate a body of evidence to provide data to incorporate CBCT into the diagnostic work-up of breast lesions.

Conditions

Interventions

DEVICE

Computed Tomography

In Group I, fifty CBCT studies will be performed. The objectives will be to illustrate the capacity of CBCT to image the breast in its entirety as compared with the gold standard mammographic exam.

DEVICE

Computed Tomography

In Group II , at least three hundred and fifty (350) study participants, who require diagnostic evaluation of the breast will undergo a breast CBCT . These subjects may be referred for biopsy as a result of a finding from a mammogram, ultrasound, MRI, or clinical exam.

Sponsors & Collaborators

  • Elizabeth Wende Breast Care, LLC

    collaborator OTHER

  • National Cancer Institute (NCI)

    collaborator NIH

  • Koning Corporation

    lead INDUSTRY

Principal Investigators

  • Posy Seifert, D.O. · Elizabeth Wende Breast Care, LLC

Eligibility

Min Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2012-12-31
Completion
2013-06-30

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 NCT01107860 on ClinicalTrials.gov