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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Paul L. Carson Ph.D, University of Michigan
ClinicalTrials.gov Identifier:
NCT00721435
First received: July 22, 2008
Last updated: May 3, 2016
Last verified: May 2016
  Purpose
The study will evaluate and refine a breast screening and diagnosis device.

Condition Intervention
Breast Cancer
Mass Cystic
Benign Mass
Procedure: 3D Tomosynthesis and ultrasound imaging

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
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 determined later. ] [ Designated as safety issue: No ]

Estimated Enrollment: 260
Study Start Date: April 2002
Estimated Study Completion Date: October 2016
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 3D Tomosynthesis & 3D Ultrasound for breast masses
Evaluate breast screening diagnostic device, 3D tomosynthesis. Assess utility of adding 3D ultrasound.
Procedure: 3D Tomosynthesis and ultrasound imaging
3D tomosynthesis & ultrasound imaging for scanning masses or healthy breast tissue
Experimental: 3D Tomosynthesis/ 3D Ultrasound for healthy subjects
Evaluate breast screening diagnostic device, 3D tomosynthesis. Assess utility of adding 3D ultrasound.
Procedure: 3D Tomosynthesis and ultrasound imaging
3D tomosynthesis & ultrasound imaging for scanning masses or healthy breast tissue

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   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00721435

Locations
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109-0554
University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Investigators
Principal Investigator: Paul L Carson, PHD University of Michigan
  More Information

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)  R01CA091713 
Study First Received: July 22, 2008
Last Updated: May 3, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

ClinicalTrials.gov processed this record on September 28, 2016