Multimode Laser Optoacoustic Ultrasonic Tomography System for Breast Cancer Care
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Number of images successfully obtained from laser optoacoustic and ultrasonic imaging system assembly (LOUISA) 3-dimensional (3D)
研究概览
简要总结
This clinical trial studies laser optoacoustic and ultrasonic imaging system assembly in finding changes in tumors in patients with breast cancer. Diagnostic procedures, such as laser optoacoustic and ultrasonic imaging system assembly, may help find and diagnose breast cancer and find out how far the disease has spread.
详细描述
PRIMARY OBJECTIVES:
I. To successfully obtain images from laser optoacoustic and ultrasonic imaging system assembly (LOUISA) 3-dimensional (3D) and assess pathology in order to guide image calibration and gain knowledge about LOUISA 3D capabilities to detect and differentiate breast tumors.
II. Estimate and compare the false positive rate of LOUISA-3D compared to standard of care ultrasound for detecting breast cancer in year 5 of the study.
SECONDARY OBJECTIVES:
I. Determine optimal scanning parameters by assessing certain machine parameters (e.g. illumination and detection conditions, laser pulse repetition rate, laser ultrasound emission characteristics, type of imaging probe, two-dimensional images vs three-dimensional images, coupling medium characteristics, software and firmware, etc.), anatomical information (speed of sound image, acoustic attenuation image, acoustic scattering image), and functional information (total hemoglobin distribution [THb]/image of angiogenesis density, image of blood oxygen saturation [SO2], and image of water distribution).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Mass palpable or nonpalpable
- •Tissue density - all tissue types
- •Menses - any stage of cycle
- •Suspicious breast mass(es) defined by mammography or ultrasound indicating biopsy is needed (biopsy not needed if previous biopsy results are available on target lesion[s])
- •Tumor location - the mammography or ultrasound report should not say that the tumor is in close proximity of chest wall
- •Any tumor type (patients with inflammatory breast cancer may be included)
排除标准
- •Patient is unable or unwilling to give informed consent for any reason
- •Disability (psychiatric, neurological or physical, which precludes examination)
- •Patient has tattoos on the region of interest
- •Overweight over 250 pounds (LB)
- •Very large breast size exceeding 6 inch diameter
- •Patient has body piercing jewelry through the nipple that cannot be removed
- •Patient has had a core or excisional biopsy in the ipsilateral breast within the last 2 weeks (patients with previous fine needle aspirations but no ultrasound evidence of hematoma or post biopsy [bx] change may be included)
- •Patient has inflammatory skin disease (i.e., psoriasis, eczema) or other irritation affecting the breast
- •Patient has any pain or high sensitivity in the breast
- •Currently taking hormonal replacement therapy
- •Non-ambulatory or unable to comply with exam
- •Pregnant (pregnancy test is not required, only as confirmed by patient)
- •Breastfeeding
- •Prior breast treatment for target lesion
- •Previous surgery of the breast in the last 3 months
结局指标
主要结局
Number of images successfully obtained from laser optoacoustic and ultrasonic imaging system assembly (LOUISA) 3-dimensional (3D)
时间窗: Within 7 days of the standard of care ultrasound
Pathology will provide useful information including but not limited to type of malignancy, tissue type, and other qualitative information that is necessary for image calibration.
False positive rate of LOUISA 3D and standard of care ultrasound
时间窗: Within 7 days of the standard of care ultrasound
McNemar's test will be used to compare paired proportions and relative false positive rates.
次要结局
未报告次要终点