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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hologic, Inc.
ClinicalTrials.gov Identifier:
NCT01433640
First received: September 9, 2011
Last updated: November 21, 2013
Last verified: November 2013
  Purpose

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
Breast Cancer

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Hologic, Inc.:

Primary Outcome Measures:
  • A PILOT study to determine Cancer lesion enhancement with CEM and CEBT is non-inferior to that of CEMRI. [ Time Frame: Fall 2012 ] [ Designated as safety issue: No ]

    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:
  • Comparison of lesion conspicuity [ Time Frame: up to one year post study enrollment ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 70
Study Start Date: July 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders 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.

Criteria

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).
  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: NCT01433640

Locations
United States, Colorado
Rose Medical Center
Denver, Colorado, United States, 80220
Sponsors and Collaborators
Hologic, Inc.
Investigators
Principal Investigator: John Lewins, MD Rose Breast Center
  More Information

Publications:

Responsible Party: Hologic, Inc.
ClinicalTrials.gov Identifier: NCT01433640     History of Changes
Other Study ID Numbers: 11-01
Study First Received: September 9, 2011
Last Updated: November 21, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on July 22, 2014