Combined Digital X-ray and Ultrasound Technique for Improved Detection and Characterization of Breast Lesions

This study is currently recruiting participants.
Verified December 2012 by University of Michigan
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Paul L. Carson Ph.D, University of Michigan
ClinicalTrials.gov Identifier:
NCT00721435
First received: July 22, 2008
Last updated: December 1, 2012
Last verified: December 2012
  Purpose

The study will evaluate and refine a breast screening and diagnosis device.


Condition Intervention
Breast Cancer
Mass Cystic
Benign Mass
Procedure: Tomosynthesis and ultrasound imaging

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Combined Digital X-ray and Ultrasound Technique for Improved Detection and Characterization of Breast Lesions

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • To have a device that produces 3D/ultrasound imaging of the breast at the same time and in the same position. [ Time Frame: To be determned later. ] [ Designated as safety issue: No ]

Estimated Enrollment: 260
Study Start Date: April 2002
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Evaluating a non-invasive breast screening and diagnostic device, 3D tomosynthesis and 3D ultrasound. Evaluate the utility of adding ultrasound.
Procedure: Tomosynthesis and ultrasound imaging
3D and ultrasound imaging for breast abnormalities and masses

Detailed Description:

The device produces 3-D mammograms and ultrasound pictures of the breast at the same time and in the same position. This should help make sure that any area on a mammogram can be easily found in the ultrasound when using the new device. The 3-D mammograms should provide better visualization of the suspected lesion and improve diagnostic accuracy.

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • To participate in this research study you must be a female over the age of 25
  • Have had a normal mammogram or are scheduled for a breast biopsy
  • Have cysts or have been recommended to have a 6 month follow up mammogram after your biopsy.

Exclusion Criteria:

  • Male
  • Under the age of 25
  • Documented breast cancer
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00721435

Contacts
Contact: Paul L Carson, PHD 734 763-5884 pcarson@umich.edu

Locations
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48109-0554
Contact: Jeanne Hill, LPN    734-647-9546    jemhill@umich.edu   
Sponsors and Collaborators
University of Michigan
Investigators
Principal Investigator: Paul L Carson, PHD University of Michigan
  More Information

No publications provided

Responsible Party: Paul L. Carson Ph.D, Principal Investigator, University of Michigan
ClinicalTrials.gov Identifier: NCT00721435     History of Changes
Other Study ID Numbers: HUM00045519 (2002-0584)
Study First Received: July 22, 2008
Last Updated: December 1, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 15, 2014