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

March 17, 2015 updated by: Hologic, Inc.

Evaluation of Contrast-enhanced Mammography and Contrast-enhanced Breast Tomosynthesis: Comparison to Contrast-enhanced Breast 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.

Study Overview

Status

Completed

Conditions

Breast Cancer

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Colorado
  - Denver, Colorado, United States, 80220
    - Rose Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Fall 2012

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to one year post study enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hologic, Inc.

Investigators

Principal Investigator: John Lewins, MD, Rose Breast Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

November 1, 2013

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

September 9, 2011

First Submitted That Met QC Criteria

September 12, 2011

First Posted (Estimate)

September 14, 2011

Study Record Updates

Last Update Posted (Estimate)

March 18, 2015

Last Update Submitted That Met QC Criteria

March 17, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

11-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.