Comparison of Low-dose Spiral Breast CT With MRI in Major Indications of MRI for Breast Diagnostics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 293
- 试验地点
- 4
- 主要终点
- Non-inferiority of CE-BCT compared with CE-MRI in Breast Cancer diagnosis
研究概览
简要总结
Comparison between two diagnostic modalities for breast cancer diagnosis. Two different imaging systems are compared to evaluate the performance of the two systems
详细描述
The diagnostic quality of MRI of the breast has made this method a gold standard in the imaging of senologic lesions. Low-dose dedicated breast CT (BCT) with single photon-detection (nu:view, developed by AB-CT - Advanced Breast-CT GmbH) has emerged as a fully 3D imaging modality that uses ionizing radiation comparable to 2D mammography and has its intended use in helping with diagnosis in diagnostic breast imaging.
The investigation is designed as a prospective non-randomized intra-individual cohort procedure comparison between the imaging platforms, nu:view and MRI. Across 3 hospital-based study sites in two countries, study participants (patients who meet study criteria and have consented) sequentially receive nu:view imaging and, with a delay of up to one week (preferably on the same day), MRI imaging. At both times, patients receive contrast agent. Images generated from breasts are evaluated by three independent radiologists and their scores and interpretations are statistically evaluated. The research aim is to demonstrate non-inferiority of BCT compared with MRI in major indications of MRI for breast diagnostics.
The perceived gain in the study is to generate data on clinical performance of the BCT device nu:view and on the procedure that could be supportive of a tailored use of nu:view in patients with major indications of MRI for breast diagnostics.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Sex: female
- •Age: at least 18 years
- •Inconclusive findings in conventional imaging or preoperative staging or evaluation of therapy response in the neoadjuvant chemotherapy setting or imaging of the breast after breast-conserving therapy or finding the cause of hemorrhagic nipple discharge or prosthesis imaging or screening of women with hereditary or familial increased risk for the development of breast cancer or axillary lymph node metastasis suspected to originate from breast tissue
- •Persons able and willing to understand and sign informed consent form
排除标准
- •Known pregnancy or breastfeeding
- •Presence of BRCA1 or BRCA2 allele
- •Insufficient renal function (MDRD)
- •Dysfunction of the thyroid gland (TSH degradation)
- •Known allergy or intolerance against iodine-containing contrast enhancing agents or MRI contrast enhancing agents
- •Patients with paramagnetic or magnetic material inside the breast, claustrophobia
研究组 & 干预措施
Imaging Breast Diagnostic
Imaging breast diagnostic where patients receive both modalities MRI and B-CT to compare the resolution of the two different diagnostic devices in the same patient
干预措施: Injection of contrast enhancing agent Gadovist for MRI investigation (Diagnostic Test)
Imaging Breast Diagnostic
Imaging breast diagnostic where patients receive both modalities MRI and B-CT to compare the resolution of the two different diagnostic devices in the same patient
干预措施: Injection of contrast enhancing agent Imeron for B-CT investigation (Diagnostic Test)
结局指标
主要结局
Non-inferiority of CE-BCT compared with CE-MRI in Breast Cancer diagnosis
时间窗: one year
The primary objective is to demonstrate non-inferiority of CE-BCT with CE-MRI in the BI-RADS detection at the lesion level in the diagnosis of eight indications for CE-MRI diagnosis. Patients with with major indications of CE-MRI will receive an additional diagnosis with CE-BCT. The images of both modalities will be compared by 3 independent raters which were randomly assigned to pseudonymized images. That rating follow the six BI-RADS Scales on lesion basis. The descriptive data will be compared according the evaluated BI-RADS scores of the raters and both modalities. For the non-inferiority test, the mean difference of lesion-wise BI-RADS scores between modalities will be used; it is expected that the mean BI-RADS values at lesion level are almost equal for both modalities.
次要结局
- Collect data for comfort of CE-BCT and CE-MRI(one year)