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Completed

NCT Number: NCT01433640

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

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.

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Key information

Age range

25 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Rose Medical Center

Denver, Colorado, 80220, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hologic, Inc.

Industry

Registry information

Official study title

Evaluation of Contrast-enhanced Mammography and Contrast-enhanced Breast Tomosynthesis: Comparison to Contrast-enhanced Breast MRI- A Pilot Study

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Sep 14, 2011
Registry last updated
Mar 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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