Digital Breast Tomosynthesis Versus Contrast Enhanced Magnetic Resonance Imaging (MRI) for Breast Cancer Staging
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).
Ductal Carcinoma In Situ
Invasive Breast Cancer
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||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|
- 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. [ Time Frame: surgical pathology results completed ] [ Designated as safety issue: No ]
- 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 [ Time Frame: surgical pathology results completed ] [ Designated as safety issue: No ]
- Predicted re-excision rates based on size estimates from each imaging paradigm [ Time Frame: surgical pathology results completed ] [ Designated as safety issue: No ]
- Patient satisfaction survey for DBT and CEMRI imaging [ Time Frame: patient completion of DBT and CEMRI imaging ] [ Designated as safety issue: No ]
|Study Start Date:||February 2009|
|Estimated Study Completion Date:||August 2016|
|Estimated Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
Women shown to have DCIS or invasive breast cancer by fine needle aspiration cytology and/or core needle biopsy.
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01060085
|United States, New Hampshire|
|Dartmouth-Hitchcock Medical Center|
|Lebanon, New Hampshire, United States, 03756|
|Principal Investigator:||Steven P Poplack, MD||Dartmouth-Hitchcock Medical Center|