N/A
N=72
Breast Displacement and CT Radiation Dose
Computed Tomography · Radiation Dosage
Bottom Line
View on ClinicalTrials.gov: NCT01261559 ↗Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Nov 2013
Primary outcome: Primary: Skin Entrance Radiation Dose During Computed Tomography (CT) — 1775; 1325; 625; 259 mrad
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Chrysalis breast displacement device (Device)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Washington
- Primary completion
- Feb 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Skin Entrance Radiation Dose During Computed Tomography (CT) |
1775; 1325; 625; 259 | — |
| PRIMARY Relative Skin Entrance Radiation Dose in % During Computed Tomography (CT) |
37; 36 | 0.003 sig |
| SECONDARY CT Image Noise |
17.1; 16.4; 23.2; 21.1; 26.8; 24.5 | — |
| SECONDARY Number of Participants With Presence of Artifacts Based on CT Image Quality |
0; 0 | — |
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.
Eligibility Criteria
Inclusion Criteria
- scheduled for CT of the abdomen and pelvis at Harborview Medical Center
- able to provide written informed consent
Exclusion Criteria
- Inability to provide written consent for self (minor, intubated, sedated, mentally incapacitated, in excessive physical distress)
- Chest or breast surgery within the previous 8 weeks
- Breast implants
- Open wounds to the chest wall
- Fractures of the ribs or spine within the previous 3 months
- Patients requiring oxygen therapy
- Mastectomy
- Breast radiation therapy
- Scarring to the breasts which would prevent displacement
- Claustrophobia is not an absolute exclusion criterion, but patient comfort will be a primary concern.
Data sourced from ClinicalTrials.gov (NCT01261559). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.