Working... Menu

Dual-energy Contrast-enhanced (2D and 3D Mammography Versus Contrast-enhanced MRI)- A Pilot Study

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: NCT01433640
Recruitment Status : Completed
First Posted : September 14, 2011
Last Update Posted : March 18, 2015
Information provided by (Responsible Party):
Hologic, Inc.

Brief Summary:
This is a pilot study to evaluate 2D contrast-enhanced mammography image and 3D (tomosynthesis) contrast-enhanced images to contrast enhanced MRI in women with greater than 95% probability of breast cancer (BIRADS 5) or confirmed breast cancer (BIRADS 6).This study will then be used to design additional studies.

Condition or disease
Breast Cancer

Layout table for study information
Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Contrast-enhanced Mammography and Contrast-enhanced Breast Tomosynthesis: Comparison to Contrast-enhanced Breast MRI- A Pilot Study
Study Start Date : July 2011
Actual Primary Completion Date : November 2013
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mammography

Contrast-enhanced Mammography
Subjects will undergo 2D imaging with iodine contrast.
Contrast-enhanced Breast Tomosynthesis
Subjects will undergo 3D imaging with iodine contrast.
Contrast-enhanced MRI
Each subject imaged with iodine contrast will also be imaged with contrast-enhanced MRI using gadolinium.

Primary Outcome Measures :
  1. A PILOT study to determine Cancer lesion enhancement with CEM and CEBT is non-inferior to that of CEMRI. [ Time Frame: Fall 2012 ]

    This Pilot study is designed to evaluate two x-ray contrast methods with contrast enhanced MRI. Each subject will be imaged with CEM, CEBT and CEMRI. The goals for this will be to:

    i) Using a Likert scale, Compare the enhancement of breast cancer lesions with CEM, CEBT and CEMRI.

    ii) Using a Likert scale, Compare the enhancement of benign breast lesions with CEM, CEBT and CEMRI.

    The results of this study will be used to design studies to measure the sensitivity and specificity of CEM and CEBT.

Secondary Outcome Measures :
  1. Comparison of lesion conspicuity [ Time Frame: up to one year post study enrollment ]
    Using a Likert scale the CEM and the CBT images will be compared with standard pre-contrast mammography and tomosynthesis images to determine lesion conspicuity.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The study population includes females of any race and ethnicity. The subjects must ba at least 25 years old and has a lesion of BIRADS 5 or BIRADS 6 as determined by a radiologist.

Inclusion Criteria:

  • Subject is a female of any race and ethnicity.
  • Subject is at least 25 years old
  • Subject has or will have a contrast enhanced breast MRI +/- 31 days of enrollment with no interval treatment or procedure between the two studies
  • Subject has BIRADS 6 or BIRADS 5 cancer or as determined by the radiologist
  • >50% of the biopsied cancer mass must remain following biopsy OR
  • A calcification must be at least 2cm in maximum dimension prior to biopsy or at least 1cm in maximum dimension following biopsy

Exclusion Criteria:

  • Subject is unable or unwilling to undergo informed consent
  • Subject has breast implant in the breast to be imaged
  • Subject is pregnant
  • Subject is breast feeding or lactating
  • Subject has a known allergy to gadolinium contrast agents.
  • Subject has a contraindication for MRI.
  • Subject suspected to be at risk to complication from the contrast agents.
  • Subject has a documented renal insufficiency,
  • Subject requires renal dialysis.
  • Subject has had a prior reaction to iodinated contrast.
  • Subject has had a prior episode of anaphylactic reaction to any substance.
  • Subject has taken metformin (Glucophage) within 48 hours of study procedures.
  • Subject has multiple allergies and/or severe asthma regularly treated with medication (prescription and/or over-the-counter).

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): NCT01433640

Layout table for location information
United States, Colorado
Rose Medical Center
Denver, Colorado, United States, 80220
Sponsors and Collaborators
Hologic, Inc.
Layout table for investigator information
Principal Investigator: John Lewins, MD Rose Breast Center


Layout table for additonal information
Responsible Party: Hologic, Inc. Identifier: NCT01433640     History of Changes
Other Study ID Numbers: 11-01
First Posted: September 14, 2011    Key Record Dates
Last Update Posted: March 18, 2015
Last Verified: March 2015

Keywords provided by Hologic, Inc.:
image on multi-modalities
visualize cancer lesions
highly suspicious lesions