Diagnostic Performance of an Automated Breast Ultrasound System (ABUS): a Single Centre Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Population D: number of participants with suspected rupture of breast implants diagnosed with ABUS compared to breast MRI diagnosis
研究概览
简要总结
The purpose of this study is to evaluate the diagnostic performance of a new ABUS system among 4 different population:
Population A: women undergoing screening for familial or genetic predisposition for breast cancer.
Population B: women with newly diagnosed breast cancer. ABUS performance will be compared to breast MRI in the pre-operative assessment of breast cancer extent.
Population C: women with BI-RADS 3 or 4 lesions in a routine breast imaging examination. ABUS will be evaluate as a problem-solving tool.
Population D: women undergoing breast MRI for the assessment of breast implants integrity. ABUS performance will be compared to breast MRI.
详细描述
Population A: women in the age range of 20 to 40 years, with a strong family history of breast cancer or a predisposing gene mutation such as BRCA1 or BRCA2. A total of 100 patients should be enrolled.
Population B: women with new breast cancer diagnosis undergoing pre-operative local cancer staging.A total of 50 patients will be enrolled.
Population C: women with lesions classified BI-RADS 3 or 4 in a routine breast imaging examination. A total of 50 patients will be enrolled.
Population D: women undergoing breast-MRI for the evaluation of breast implants integrity. A total of 50 patients will be enrolled.
The expected duration of subject participation is 5 years for population A: every year the patients will undergo ABUS examination and the results will be compared with HHUS examination.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Population A - Inclusion criteria:
- •Age between 20 and 40 years
- •family history of breast cancer or a proved predisposing gene mutation such as BRCA1 or BRCA2
- •Population B - Inclusion criteria
- •Age ≥ 18 years
- •Newly diagnosed breast cancer with no previous history of breast cancer
- •Availability of pre-operative breast MRI performed for local staging within 4 weeks before the surgery
- •Breast surgery performed at the UniversitätsSpital Zürich
- •Population C - Inclusion criteria
- •Age ≥ 18 years
- •Newly detected BI-RADS 3 or 4 lesion
- •Availability of follow-up examination or histological results of biopsy and surgery
- •Population D - Inclusion criteria
- •Age ≥ 18 years
- •Availability of breast MRI performed for evaluating breast implants integrity
排除标准
- •Population A - Exclusion criteria:
- •Personal history of breast or ovarian cancer
结局指标
主要结局
Population D: number of participants with suspected rupture of breast implants diagnosed with ABUS compared to breast MRI diagnosis
时间窗: 5 years
sensitivity and specificity of a new ABUS system in the assessment of breast implants integrity. Breast MRI will be used as standard of reference
Population B:comparison between ABUS and breast MRI with respect to known malignant lesion/s size assessment and number of additional lesions detected and not previously evident with mammography and HHUS
时间窗: 5 years
sensitivity and specificity of a new ABUS system in the assessment of breast cancer extent. Breast MRI will be used as standard of reference
Population A: comparison between ABUS and HHUS with respect to the number of lesions detected with the two devices and their characterization according to the BI-RADS lexicon
时间窗: 5 years
Population C: number of patients with diagnosis of BI-RADS 3 and 4 breast lesions with ABUS compared to histological results or follow-up
时间窗: 5 years
sensitivity and specificity of a new ABUS system in the assessment of BI-RADS 3 and 4 lesions. Follow-up and histological results of the biopsy or surgery will be used as standard of reference
次要结局
未报告次要终点