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


N/A
25 Years
N/A
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

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


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).

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

Fall 2012

Safety Issue:

No

Principal Investigator

John Lewins, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Rose Breast Center

Authority:

United States: Institutional Review Board

Study ID:

11-01

NCT ID:

NCT01433640

Start Date:

July 2011

Completion Date:

September 2013

Related Keywords:

  • Breast Cancer
  • image on multi-modalities
  • visualize cancer lesions
  • highly suspicious lesions
  • Breast Neoplasms

Name

Location

Rose Medical CenterDenver, Colorado  80220