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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01433640

Enrollment

Registered

2011-09-14

Start date

2011-07-31

Completion date

2014-02-28

Last updated

2015-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

image on multi-modalities, visualize cancer lesions, highly suspicious lesions

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

25 Years to No maximum

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results