Comparison Study of Breast Tomosynthesis Slice Thicknesses

NCT00957567 | Completed

• 1 other identifier: IRB00008667
• Study Type: observational
• Target: 182
• Locations: 1 country
• Sites: 1

Brief Summary

Early diagnosis is one of the most important factors in the survival of patients diagnosed with breast cancer. To aid in the early detection of breast cancer, a new technology, called tomosynthesis imaging is being developed. The idea behind tomosynthesis imaging is to "look" at the breast from different points of view by obtaining x-ray flat images from different angles while the breast does not move, and then mathematically combine these flat images into a three-dimensional image. The benefit of these three dimensional images is that the radiologist can look at the different tissues of the breast in their real positions, as opposed to all the tissues being "flattened" into a flat image, like that of a normal mammogram. Since tomosynthesis images of the breast show the tissues in their real position, the radiologist should be able to more easily find a tumor and also be able to reduce the number of time he or she thinks there is a tumor present when in reality there is not one there. Before this new technology can be used in the clinic routinely, it is necessary to perform a large number of studies to find the optimal way to use it. In this study, the investigators are aiming to find how thick the slices or layers representing the breast should be in the image when shown to the radiologist. The difference between these two thicknesses in how useful the images are to the radiologist could be important. The investigators are trying to determine if slicing the image of the breast into thicker slices will make the job of the radiologist easier or not when deciding to recommend or not a biopsy (laboratory analysis) of what the previous mammogram found. To find the answer to this question, the investigators will image patients with their tomosynthesis machine and look at the tomosynthesis images with the thin and thick slices. The radiologists that read each image will decide if they would have recommended the patient to get a biopsy based only in each of these images. The recommendations based on the images with thin slices and the recommendations based on the images with thick slices will be compared with what was actually recommended using the standard clinical tests. The investigators hope to find that the thicker slices help more than the thinner slices when trying to decide if biopsy is needed or not.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Equivalence in diagnostic accuracy

  After biopsy or follow-up

Eligibility Criteria

• Age: 35 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The target population for this study is women who are recalled for an abnormal finding on a screening mammogram.

You may qualify if:

• Women with suspected or confirmed pregnancy
• Women who have had bilateral mastectomy
• Women with large breasts that cannot be accommodated within the field of view of the tomosynthesis system
• Women who are very frail and unable to cooperate
• Women who are under 35 years of age
• Women who cannot give informed consent
• Male subjects
• Women with implants
• Subject has had breast augmentation, except for unilateral augmentation done for prior mastectomy

Sponsors & Collaborators

• Emory University: lead
• Hologic, Inc.: collaborator

Study Sites (1)

Emory University Hospital Breast Imaging Center

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Mary Newell, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 11, 2009
• First Posted: August 12, 2009
• Study Start: April 1, 2009
• Primary Completion: September 1, 2011
• Study Completion: December 1, 2012
• Last Updated: November 21, 2013

Record last verified: 2013-11

Locations

US (1)