Effect of Displacement During Computed Tomography on Breast Radiation Dose and Image Quality
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Skin Entrance Radiation Dose During Computed Tomography (CT)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •scheduled for CT of the abdomen and pelvis at Harborview Medical Center
- •able to provide written informed consent
排除标准
- •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.
研究组 & 干预措施
Standard CT
Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) but without the Chrysalis device.
Chrysalis CT
Women assigned to undergo CT using the standard dose reduction methods (including bismuth shielding and tube current modulation) plus application of the Chrysalis device for breast displacement.
干预措施: Chrysalis breast displacement device (Device)
结局指标
主要结局
Skin Entrance Radiation Dose During Computed Tomography (CT)
时间窗: from time potential subject approached about possible enrollment to time device and TLDs were removed, on average 1 hour
Skin entrance radiation doses will be measured with Thermoluminescent dosimeters (TLDs) affixed to the subject's chest and breast during CT of the abdomen. TLD #1 is at the inframammary fold, serving as internal control for each subject. Three additional TLDs (#2-4) are affixed to the subject's breast at 3 pre-ascribed locations. The same is done for the right and left breasts (8 TLDs total). TLDs will then be submitted to Landaeur for measurement.
Relative Skin Entrance Radiation Dose in % During Computed Tomography (CT)
时间窗: from time potential subject approached about possible enrollment to time device and TLDs were removed, on average 1 hour
Relative skin entrance dose at the breast (group mean of patient's average skin entrance dose at TLDs 2-4) divided by skin entrance dose at the inframammary TLD (TLD 1) in %. For each patient, doses at TLDs 2-4 were averaged, and then the group mean of this was divided by the group mean at the inframammary TLD, then multiplied by 100 to get % dose. A relative dose of 20% means that the skin entrance dose at the breast was 20% of the skin entrance dose at the inframammary fold.
次要结局
- Number of Participants With Presence of Artifacts Based on CT Image Quality(two months)
- CT Image Noise(two months)
研究者
Claire Kalsch Sandstrom
Fellow, Section of Emergency Radiology, Department of Radiology
University of Washington