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

Women at Increased Risk for Developing Breast Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01716247
• Other study ID #: 12-214
• Status: Completed
• Phase: N/A
• Start date: October 2012
• Est. completion date: June 2018

Study information

• Verified date: June 2018
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if Contrast Enhanced Spectral Mammography (CESM) will be able to detect smaller/earlier breast cancers as well as breast MRI can.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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 - contrast agent (i.e., allergy to iodinated contrastor 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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Women at Increased Risk for Developing Breast Carcinoma

Intervention

Other:
• Mammography (CESM) and MRI
The study consists of the addition of a single contrast enhanced digital mammography examination (CESM) to the routine screening of a woman at increased risk for breast cancer who is also having a breast MRI. Breast MRIs will be read by the radiologist reading breast MRIs on any given day. CESM is a dedicated system, derived from a standard digital mammography unit modified to deliver the dual or multiple energy exposures and visualization of combined images after IV contrast administration. If the patient is having her routine mammogram within 30 days of her MRI, CESM can replace that mammogram Patients will be randomly assigned to one of the radiologists trained to interpret CESM. That radiologist will read the CESM blinded to the results of the breast MRI.This process will be monitored by the research assistant No radiologist will read both the breast MRI and CESM on the same patient.

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Cancer Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	compare the sensitivity and specificity CESM	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.	1 year

External Links

•   Memorial Sloan Kettering Cancer Center