Clinical trial NCT01261559: Breast Displacement and CT Radiation Dose
Official title: Effect of Displacement During Computed Tomography on Breast Radiation Dose and Image Quality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Computed Tomography
Radiation Dosage
Keywords: Computed tomography
Radiation dose
Dose reduction
Breast displacement
Chrysalis device
Image quality
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2010-12-16
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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.

Primary outcomes:
measure: Skin Entrance Radiation Dose During Computed Tomography (CT)
timeFrame: from time potential subject approached about possible enrollment to time device and TLDs were removed, on average 1 hour
measure: Relative Skin Entrance Radiation Dose in % During Computed Tomography (CT)
timeFrame: from time potential subject approached about possible enrollment to time device and TLDs were removed, on average 1 hour
Secondary outcomes:
measure: CT Image Noise
timeFrame: two months
measure: Number of Participants With Presence of Artifacts Based on CT Image Quality
timeFrame: two months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
Study officials:
affiliation: University of Washington Department of Radiology
name: Claire K Sandstrom, MD
role: PRINCIPAL_INVESTIGATOR
References:
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