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

Completed

Conditions studied: Ductal Carcinoma In Situ, Invasive Breast Cancer

In brief

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).

Key facts

Study ID

NCT01060085

Run by

Dartmouth-Hitchcock Medical Center

People needed

51

Starts

2009-02-01

Expected to finish

2016-12-31

Last updated by the study team

2017-02-23

Who can join

Age: 30 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States

Full record on ClinicalTrials.gov

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