Clinical Trials Directory

Trials / Completed

CompletedNCT01261559

Breast Displacement and CT Radiation Dose

Effect of Displacement During Computed Tomography on Breast Radiation Dose and Image Quality

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
72 (actual)
Sponsor
University of Washington · Academic / Other
Sex
Female
Age
18 Years – 60 Years
Healthy volunteers
Not accepted

Summary

The primary hypothesis of this study is that breast displacement out of the direct plane of imaging during computed tomography (CT) of the abdomen will reduce effective radiation dose to the female breast. Secondary hypotheses are that image noise and artifacts will also be decreased.

Detailed description

Computed tomography (CT) is a significant source of medical-related radiation, and radiation-related cancer risk is increasingly recognized in the medical and lay community. One of the groups at greatest risk for radiation-induced malignancies is young females due to the radiosensitivity of female breast tissue. Breast tissue frequently lies within the imaging plane for CT of the abdomen with limited gain in diagnostic information. We propose displacing this breast tissue out of the direct imaging plane will decrease unnecessary radiation exposure and may also indirectly improve image quality. A device called Chrysalis has been designed and received FDA approval for the purposes of displacing female breast tissue during CT.

Conditions

Interventions

TypeNameDescription
DEVICEChrysalis breast displacement deviceChrysalis is a cloth device secured with velcro and buckles around the upper abdomen and chest following manual cephalad breast displacement.

Timeline

Start date
2010-12-01
Primary completion
2012-02-01
Completion
2012-02-01
First posted
2010-12-16
Last updated
2018-07-06
Results posted
2013-11-05

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01261559. Inclusion in this directory is not an endorsement.