Digital Breast Tomosynthesis Versus Contrast Enhanced Magnetic Resonance Imaging (MRI) for Breast Cancer Staging
This study is ongoing, but not recruiting participants.
Sponsor:
Dartmouth-Hitchcock Medical Center
Collaborator:
Hologic, Inc.
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT01060085
First received: January 29, 2010
Last updated: December 12, 2012
Last verified: December 2012
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Purpose
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 |
|---|
|
Ductal Carcinoma In Situ Invasive Breast Cancer |
| Study Type: | Observational |
| 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 |
Resource links provided by NLM:
Further study details as provided by Dartmouth-Hitchcock Medical Center:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
| Estimated Enrollment: | 50 |
| Study Start Date: | February 2009 |
| Estimated Study Completion Date: | June 2013 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Breast Cancer
Women shown to have DCIS or invasive breast cancer by fine needle aspiration cytology and/or core needle biopsy.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 30 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Women who have histologically proven, non-inflammatory, breast cancer.
Criteria
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:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01060085
Locations
| United States, New Hampshire | |
| Dartmouth-Hitchcock Medical Center | |
| Lebanon, New Hampshire, United States, 03756 | |
Sponsors and Collaborators
Dartmouth-Hitchcock Medical Center
Hologic, Inc.
Investigators
| Principal Investigator: | Steven P Poplack, MD | Dartmouth-Hitchcock Medical Center |
More Information
No publications provided
| Responsible Party: | Dartmouth-Hitchcock Medical Center |
| ClinicalTrials.gov Identifier: | NCT01060085 History of Changes |
| Other Study ID Numbers: | D0842 |
| Study First Received: | January 29, 2010 |
| Last Updated: | December 12, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Dartmouth-Hitchcock Medical Center:
|
Breast Cancer |
Additional relevant MeSH terms:
|
Breast Neoplasms Carcinoma Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Carcinoma, Ductal, Breast Carcinoma, Ductal Neoplasms by Site |
Neoplasms Breast Diseases Skin Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Adenocarcinoma Neoplasms, Ductal, Lobular, and Medullary |
ClinicalTrials.gov processed this record on May 16, 2013