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

NCT01060085 | Completed DMC

• 1 other identifier: D0842
• Study Type: observational
• Target: 51
• Locations: 1 country
• Sites: 1

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. 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. 2.Comparison of re-excision rates based on estimated disease extent from adjunctive CEMRI vs. adjunctive DBT.
3. 3.Evaluation of patient satisfaction with regard to the adjunctive modality (DBT vs. CEMRI).

Conditions

Ductal Carcinoma In Situ; Invasive Breast Cancer

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (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.

  surgical pathology results completed

Secondary Outcomes (3)

• 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

  surgical pathology results completed

• Predicted re-excision rates based on size estimates from each imaging paradigm

  surgical pathology results completed

• Patient satisfaction survey for DBT and CEMRI imaging

  patient completion of DBT and CEMRI imaging

Study Arms (1)

Breast Cancer

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

Eligibility Criteria

• Age: 30 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women who have histologically proven, non-inflammatory, breast cancer.

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

Sponsors & Collaborators

• Dartmouth-Hitchcock Medical Center: lead
• Hologic, Inc.: collaborator

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Carcinoma, Intraductal, Noninfiltrating; Breast Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Steven P Poplack, MD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2010
• First Posted: February 2, 2010
• Study Start: February 1, 2009
• Primary Completion: December 31, 2016
• Study Completion: December 31, 2016
• Last Updated: February 23, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)