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

Completed

• Conditions: Breast Cancer

• Registration Number: NCT01433640
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-09-09
• Study First Submitted QC: 2011-09-12
• Study First Posted: 2011-09-14
• Primary Completion: 2013-11
• Study Completion: 2014-02
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-17
• Last Update Posted: 2015-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A PILOT study to determine Cancer lesion enhancement with CEM and CEBT is non-inferior to that of CEMRI.	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

Name	Time	Method
Comparison of lesion conspicuity	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.

Trial Locations

Locations (1)

Rose Medical Center; 🇺🇸 Denver, Colorado, United States