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Digital Breast Tomosynthesis Versus Contrast Enhanced Magnetic Resonance Imaging (MRI) for Breast Cancer Staging

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01060085
Recruitment Status : Completed
First Posted : February 2, 2010
Last Update Posted : February 23, 2017
Hologic, Inc.
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center

Brief Summary:

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:

  1. Comparing the operating characteristics of each combined imaging protocol with respect to the reference standard, i.e. histopathologic assessment, of additional non-index lesions.
  2. Comparison of re-excision rates based on estimated disease extent from adjunctive CEMRI vs. adjunctive DBT.
  3. Evaluation of patient satisfaction with regard to the adjunctive modality (DBT vs. CEMRI).

Condition or disease
Ductal Carcinoma In Situ Invasive Breast Cancer

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Study Type : Observational
Actual Enrollment : 51 participants
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
Study Start Date : February 2009
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : December 31, 2016

Resource links provided by the National Library of Medicine

Breast Cancer
Women shown to have DCIS or invasive breast cancer by fine needle aspiration cytology and/or core needle biopsy.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. Predicted re-excision rates based on size estimates from each imaging paradigm [ Time Frame: surgical pathology results completed ]
  3. Patient satisfaction survey for DBT and CEMRI imaging [ Time Frame: patient completion of DBT and CEMRI imaging ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women who have histologically proven, non-inflammatory, breast cancer.

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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:

    1. presence of implanted electrical device (pacemaker or neurostimulator),aneurysm clip, or metallic foreign body in or near the eyes
    2. 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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01060085

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United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Hologic, Inc.
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Principal Investigator: Steven P Poplack, MD Dartmouth-Hitchcock Medical Center
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Responsible Party: Dartmouth-Hitchcock Medical Center Identifier: NCT01060085    
Other Study ID Numbers: D0842
First Posted: February 2, 2010    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Dartmouth-Hitchcock Medical Center:
Breast Cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Carcinoma in Situ
Carcinoma, Ductal
Carcinoma, Intraductal, Noninfiltrating
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Ductal, Lobular, and Medullary
Breast Carcinoma In Situ