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
| Type | Name | Description |
|---|---|---|
| DEVICE | Chrysalis breast displacement device | Chrysalis 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.