A Comparison of the Diagnostic Accuracy of Adjunctive Digital Breast Tomosynthesis Versus Adjunctive Contrast Enhanced Breast Magnetic Resonance Imaging in the Preoperative Assessment of Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Comparison between the accuracy of DBT vs. CEMRI using two measurements: 1. Maximal diameter estimate by imaging modality and 2. Maximal diameter based on histopathology gold standard.
研究概览
简要总结
The primary objective of this study is to compare the diagnostic accuracy of Digital Breast Tomosynthesis (DBT) versus that of Contrast Enhanced Magnetic Resonance Imaging (CEMRI) in determining the size of breast cancer preoperatively.
Secondary objectives include:
- Comparing the operating characteristics of each combined imaging protocol with respect to the reference standard, i.e. histopathologic assessment, of additional non-index lesions.
- Comparison of re-excision rates based on estimated disease extent from adjunctive CEMRI vs. adjunctive DBT.
- Evaluation of patient satisfaction with regard to the adjunctive modality (DBT vs. CEMRI).
详细描述
STUDY OVERVIEW
Subjects are enrolled within 4 weeks of the date of diagnosis of biopsy proven ductal carcinoma in-situ (DCIS) or Invasive Breast Cancer. Approximately 50 subjects will be enrolled. In addition to Dartmouth-Hitchcock Medical Center's (DHMC)current standard imaging practice, i.e. bilateral mammography with or without sonography and bilateral CEMRI, all subjects will undergo bilateral DBT within four weeks of CEMRI and prior to surgical treatment. Usual clinical practice, i.e. interpretation of current standard imaging (Mammography, Sonography and CEMRI), and clinical assessment based on physical exam as well, as discussion with the patient and breast surgeon of record, will dictate local treatment, i.e. surgical excision only, breast conservation therapy (BCT) or mastectomy.
Any routine diagnostic examinations completed as part of the subject's standard of care imaging will be read and interpreted as part of the patient's standard of care. There will be no delays in reading or interpretation of the routine care images.
Blinded reads of the DBT and CEMRI images will be conducted, with the patient's mammography +/- sonography available for reference. The interpreting radiologists ("readers") will evaluate tumor size and extent of disease, along with the presence or absence of multi-focality or contralateral disease. The two imaging paradigms will be compared in the estimation of breast cancer extent using the gold-standard histologic result.
DBT mammography may provide new or different information about the index lesion than standard imaging, but this will not alter clinical management. However, if DBT detects an additional abnormality separate from the index lesion either in the ipsilateral or contralateral breast, it will be evaluated further with standard imaging technology (e.g. diagnostic mammography and or sonography) targeted to this site to assess the level of suspicion for malignancy and potential need for biopsy.
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
- 30 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject is female of any race and ethnicity
- •Subject is at least 30 years old
- •Subject has histologically proven DCIS or invasive breast carcinoma.
- •Subject is able to undergo CEMRI at DHMC-Lebanon
排除标准
- •Patients who are pregnant or think they may be pregnant
- •Patients who are breast-feeding.
- •Patients who have significant existing breast trauma
- •Subjects unable or unwilling to undergo informed consent
- •Absolute contraindication to CEMRI, including:
- •presence of implanted electrical device (pacemaker or neurostimulator),aneurysm clip, or metallic foreign body in or near the eyes
- •life threatening allergy to gadolinium contrast
- •CEMRI performed at institution other than DHMC Lebanon
- •Patients undergoing neoadjuvant therapy
- •Patients with maximum tumor diameter >5cm
- •Patients presenting with Inflammatory Breast Cancer
- •Patients with gross axillary lymphadenopathy on clinical exam or by imaging
- •Maximum breast size limitation: i.e. breast size that exceeds the size of the large format image receptor (24cm x 29cm) on any view
结局指标
主要结局
Comparison between the accuracy of DBT vs. CEMRI using two measurements: 1. Maximal diameter estimate by imaging modality and 2. Maximal diameter based on histopathology gold standard.
时间窗: surgical pathology results completed
次要结局
- Predicted re-excision rates based on size estimates from each imaging paradigm(surgical pathology results completed)
- Patient satisfaction survey for DBT and CEMRI imaging(patient completion of DBT and CEMRI imaging)
- True positives, true negatives, false positives and false negatives for: 1. Multi-focality defined as additional discrete discontinuous tumor foci that are at least 2.5 cm separate from the index lesion. 2. Contralateral disease: presence/absence(surgical pathology results completed)