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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Hologic, Inc.
Information provided by (Responsible Party):
Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier:
NCT01060085
First received: January 29, 2010
Last updated: April 29, 2014
Last verified: April 2014
  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:

  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
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: August 2014
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:

    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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: April 29, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Dartmouth-Hitchcock Medical Center:
Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma in Situ
Carcinoma, Ductal
Carcinoma, Ductal, Breast
Carcinoma, Intraductal, Noninfiltrating
Adenocarcinoma
Breast Diseases
Carcinoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Ductal, Lobular, and Medullary
Neoplasms, Glandular and Epithelial
Skin Diseases

ClinicalTrials.gov processed this record on October 30, 2014