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Comparison of Contrast Enhanced Mammography to Breast MRI in Screening Patients at Increased Risk for Breast Cancer


N/A
21 Years
N/A
Open (Enrolling)
Female
Women at Increased Risk for Developing Breast Carcinoma

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Trial Information

Comparison of Contrast Enhanced Mammography to Breast MRI in Screening Patients at Increased Risk for Breast Cancer


Inclusion Criteria:



- Women considered at increased risk for developing breast carcinoma (those with a
lifetime risk of >15%due to family history, genetic predisposition, prior radiation
therapy to the chest, prior biopsy showing a high risk lesion, or personal history of
breast cancer) that are being screened with breast MRI.

- Women who have a screening digital mammogram on the day of CESM or within 365 days
prior

Exclusion Criteria:

- Women under 21.

- Pregnant or possibly pregnant.

- Women who have a contraindication to the intravenous use of iodinated or
gadolinium-chelated contrast agent (i.e., allergy to either agent or severely
impaired renal function with a creatinine level > or = to 1.3).

- Women with breast implants.

- Women with pacemakers.

- Women with aneurysm clips that don't allow for MRI.

- Women too claustrophobic to undergo MRI.

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Outcome Measure:

compare the sensitivity and specificity CESM

Outcome Description:

CESM to that of breast MRI in a population of women who are being screened because they are at increased risk for developing breast cancer. For this purpose a positive CESM test will be defined as a score of 4 or 5. We will use the existing MRI BIRADS system to score CESM images based on the characteristics of individual lesions and increased enhancement compared to the background. A positive MRI test will be defined by a BIRADs score of 4 or 5.

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Maxine Jochelson, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

12-214

NCT ID:

NCT01716247

Start Date:

October 2012

Completion Date:

October 2014

Related Keywords:

  • Women at Increased Risk for Developing Breast Carcinoma
  • Mammography (CESM)
  • MRI
  • Breast screening
  • 12-214
  • Breast Neoplasms
  • Carcinoma

Name

Location
Memorial Sloan-Kettering Cancer Center New York, New York  10021