Digital Breast Tomosynthesis Versus Contrast Enhanced Magnetic Resonance Imaging (MRI) for Breast Cancer Staging
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|ClinicalTrials.gov Identifier: NCT01060085|
Recruitment Status : Completed
First Posted : February 2, 2010
Last Update Posted : February 23, 2017
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).
|Condition or disease|
|Ductal Carcinoma In Situ Invasive Breast Cancer|
Show Detailed Description
|Study Type :||Observational|
|Actual Enrollment :||51 participants|
|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|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||December 31, 2016|
|Actual Study Completion Date :||December 31, 2016|
Women shown to have DCIS or invasive breast cancer by fine needle aspiration cytology and/or core needle biopsy.
- 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 ]
- 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 ]
- Predicted re-excision rates based on size estimates from each imaging paradigm [ Time Frame: surgical pathology results completed ]
- Patient satisfaction survey for DBT and CEMRI imaging [ Time Frame: patient completion of DBT and CEMRI imaging ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|