Photo-Acoustic and Ultrasound MammoScope to Detect Breast Lesions: The PAUS Study
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- PAM3+ performance
研究概览
简要总结
The aim of this study is to evaluate the negative predictive value of the Photo Acoustic Imager 3+ (PAM3+) in the detection of female breast lesions (malignant and benign)in an outpatient setting.
详细描述
Secondary, the diagnostic accuracy of the PAM3+ in the localization, and sizing breast lesions in relation to BI-RADS score, breast density, and conventional imaging is evaluated. This includes assessing usability, patient satisfaction, safety, and establishing the foundation for a PAM3+ lexicon.
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
盲法说明
The PAM3+ outcomes will be assessed by an analyst that is completely masked from all other diagnostic imaging results. After receiving output from the analyst, full results will be (pseudo)anonymously shared with the analyst.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Referred to the outpatient breast clinic of the Franciscus Vlietland Hospital due to a possible breast lesion
- •Patients who are fully competent to give written informed consent
- •Sufficient knowledge of the Dutch language to complete a questionnaire
排除标准
- •Currently undergoing chemotherapy
- •Discharge from the nipple(s)
- •Breast ulcers or -wounds
- •Currently suffering from mastitis
- •Carrier of a resistant bacterium (e.g. Methicillin-resistant Staphylococcus aureus (MRSA) or Multidrug resistant organisms (MDRO; in Dutch: BRMO)
- •Irremovable piercings on/in the breast
- •Patients whose breasts do not fit in the cup sizes (small breasts can be measured without a cup)
- •Currently using medication that increases photo-toxicity of the skin or skin care products that increase photosensitivity (e.g. certain antibiotics: tetracyclines or quinolones, certain antidiuretics
- •A history of photosensitive disease (e.g. porphyria, lupus erythematosus)
- •Currently undergoing therapy for a photosensitive disease and experiencing photosensitive disease
- •Currently undergoing phototherapy
- •Patients with a known allergy for PVC
- •Patients that are not physically capable of climbing on the examination bed
- •Patients that are not physically capable of laying on the examination bed during the measurements
结局指标
主要结局
PAM3+ performance
时间窗: through study completion, an average of 1 year
To evaluate the performance of the PAM3+ system in breast imaging. Performance is defined as the negative predictive value in the detection of breast lesions (malignant and benign).
次要结局
- Sensitivity(through study completion, an average of 1 year)
- Positive predictive value(through study completion, an average of 1 year)
- Specificity of the PAM3+(through study completion, an average of 1 year)
- Differences in Performance(through study completion, an average of 1 year)
- Accuracy(through study completion, an average of 1 year)
- Mammary gland visibility(through study completion, an average of 1 year)
- Agreement(through study completion, an average of 1 year)
- Patient Satisfaction(Periprocedural)
- System usability score(Periprocedural)
- Agreement Between BI-RADS Categories Assigned by Breast Radiologists Using Conventional Imaging vs. PAM3+ 3D Imaging(through study completion, an average of 1 year)
- Adverse events(Periprocedural)
研究者
Linda Riks
MD
Franciscus Gasthuis & Vlietland (Hospital)