Evaluation of Virtual Touch Tissue Imaging Quantification (VTIQ - 2D-SWE) in the Assessment of BI-RADS® 3 and 4 Lesions: Can Patient Selection for Biopsy be Improved? - A Confirmatory Multi-Center-Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,304
- 试验地点
- 11
- 主要终点
- Standard chi-square test at a two-sided significance level of 5% to test the diagnostic accuracy of Virtual Touch Tissue Imaging Quantification (VTIQ) in the differentiation of BI-RADS® 3 and 4a lesions
研究概览
简要总结
The primary aim of this study is to evaluate if VTIQ in addition to BI-RADS® categorization can improve the diagnostic accuracy with respect to detection of malignancies, in particular for BI-RADS® categories 3 and 4a. The idea of the study is to restage all patients in categories 3 and 4a according to a predefined VTIQ cut-off value of ≥ 3.5 m/s (37 kPa).
详细描述
Elastography is a method of imaging tissue stiffness. It is based on shear wave velocity information that can be mapped to create an image of the stiffness in the region of interest.
Sonoelastography is used to differentiate benign from malignant lesions since malignant lesions alter tissue elasticity.
Adding Shear Wave elastographic features to BI-RADS® feature analysis- especially in lesions scored BI-RADS® 3 and 4a- improved specificity of breast US mass assessment without loss of sensitivity.
The BI-RADS® categories are defined by the risk for a malignant lesion varying from benign BI-RADS® 2 lesions, up to a 2% malignancy rate in BI-RADS® 3 and 2- 95% in BI-RADS® 4 (4a 2-10%; 4b 10-50%; 4c 50-95%). Based on these probabilities, biopsies are recommended for BI-RADS® 4 and 5 lesions and short-term follow-up examinations for BI-RADS® 3. Consequently, up to 2% of the in Ultrasound visible breast cancers are not directly detected as such and put into the BI-RADS® 3 category. In contrast, in the BI-RADS® 4a category more than 90% of the biopsies are unnecessary.
The main aim of the confirmatory study is to use Virtual Touch Tissue Imaging Quantification in order to reduce unnecessary benign biopsies without a reduction of the number of detected cancers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
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
- •Patients with a lesion ≥ 0.5 cm in largest diameter size, initially scored BI-RADS® 3, 4a, 4b or 4c in B-mode ultrasound
- •Informed consent about histological examination (core cut biopsy (CCB), vacuum-assisted biopsy (VAB), fine needle aspiration (FNA) or surgery) has already been given in the course of clinical routine
- •Signed informed consent of study participation
排除标准
- •Pregnant or lactating women
- •Women with breast implants on the same side as the lesion
- •Women that underwent local radiation or chemotherapy within the last 12 months
- •Women with history of breast cancer or breast surgery in the same quadrant
- •Lesions in or close to scar tissue (< 1cm)
- •Skin lesions or lesions that have been biopsied previously
- •Lesion larger than 4 cm in the longest dimension
- •No lesion should be included when more than 50% of the lesion is further down than 4 cm beneath the skin level.
研究组 & 干预措施
BI-RADS 3
Intervention: Ultrasound- Virtual Touch Tissue Imaging Quantification
干预措施: Ultrasound- Virtual Touch Tissue Imaging Quantification (Device)
BI-RADS 4a
Intervention: Ultrasound- Virtual Touch Tissue Imaging Quantification
干预措施: Ultrasound- Virtual Touch Tissue Imaging Quantification (Device)
BI-RADS 4b
Intervention: Ultrasound- Virtual Touch Tissue Imaging Quantification
干预措施: Ultrasound- Virtual Touch Tissue Imaging Quantification (Device)
BI-RADS 4c
Intervention: Ultrasound- Virtual Touch Tissue Imaging Quantification
干预措施: Ultrasound- Virtual Touch Tissue Imaging Quantification (Device)
结局指标
主要结局
Standard chi-square test at a two-sided significance level of 5% to test the diagnostic accuracy of Virtual Touch Tissue Imaging Quantification (VTIQ) in the differentiation of BI-RADS® 3 and 4a lesions
时间窗: 2 years
Hierarchical testing of the main statistical hypotheses H0_1, H0_2, H0_3 (test for H0_1 defines a gatekeeper) to evaluate the diagnostic accuracy of VTIQ in the differentiation of BI-RADS® 3 and 4a lesions: H0_1: The proportion of malignancies for group A (BI-RADS 4a, VTIQ ≥ cut-off) is less or equal to the proportion of malignancies for group B (BI-RADS 4a, VTIQ \< cut-off). versus H1_1: The proportion of malignancies for group A is higher than the proportion of malignancies for group B.
Standard Binomial-test according to Bonferroni-Holm to test the null hypothesis H0_3
时间窗: 2 years
H0_3: The proportion of malignancies for group D (BI-RADS 3, VTIQ \< cut-off) is larger than or equal to 2%. versus H1_3: The proportion of malignancies for group D is smaller than 2%.
Standard Binomial-test according to Bonferroni-Holm to test the null hypothesis H0_2
时间窗: 2 years
H0_2: The proportion of malignancies for group B (BI-RADS 4a, VTIQ \< cut-off) is larger than or equal to 2%. versus H1_2: The proportion of malignancies for group B is smaller than 2%.
次要结局
- Cohens's Kappa to test the INTER-RATER reliability for the dichotomized values(2 years)
- Robust regression models to test the INTRA-RATER reliability for the original continuous scale(2 years)
- BI-RADS® vs. BI-RADS® + Virtual Touch Tissue Imaging Quantification (VTIQ)(2 years)
- Cohens's Kappa to test the INTRA-RATER reliability for the dichotomized values(2 years)
- Corresponding chi-square tests for descriptive analysis of Virtual Touch Tissue Imaging Quantification (VTIQ) in the assessment of BI-RADS® 3, 4b, 4c lesions(2 years)
- Skin to breast lesion surface depth (cm)(2 years)
- Quality factor within the lesion assessed using a color coded scale(2 years)
- Robust regression models to test the INTER-RATER reliability for the original continuous scale(2 years)
- Descriptive analysis of predictive factors of the continuous VTIQ-value(2 years)
- Lesion size in B-mode Ultrasound (in cm)(2 years)
- Corresponding chi-square tests for descriptive analysis of the strain ratio in the differentiation of BI-RADS® 3, 4a, 4b or 4c lesions(2 years)
- Breast density/ tissue composition assessed using the morphologic characteristics on US (homogeneous background texture fat, homogeneous background texture fibroglandular, heterogeneous background texture)(2 years)
- Grading (G1, G2, G3, Gx)(2 years)
- BI-RADS® vs. histological results(2 years)
- Normal fatty tissue shear wave velocity (ratio between measurement in the fatty tissue and in the lesion)(2 years)
- Immunohistology (estrogen receptor (ER) status positive/ negative, progesterone receptor (PgR) status positive/ negative, human epidermal growth factor receptor 2 (HER2-neu) status positive/ negative, Ki-67 status (%))(2 years)
- Cohens's Kappa to determine the inter-rater reliability of BI-RADS® Assessment (local vs. central assessment)(2 years)
- Pathology (fibroadenoma, lipoma, atypia, cyst condense, "non special type" (NST), invasive lobular carcinoma (ILC), invasive tubular carcinoma (ITC), carcinoma with medullary features, papillary cancer, ductal carcinoma in situ (DCIS), others)(2 years)
- Interclass correlation coefficient (ICC) values to determine the inter-rater reliability of BI-RADS® Assessment (local vs. central assessment)(2 years)
- Chi-square test to examine whether the cut-off value of ≥ 3.5 m/s (37kPa) might be increased by increasing the cut-off value step-by-step by a small amount and repeat the primary analysis(2 years)
研究者
Michael Golatta
PD Dr. med.
Heidelberg University