Contrast-Enhanced Mammography Imaging Screening Trial (CMIST) is a study by the American College of Radiology in collaboration with the Breast Cancer Research Foundation (BCRF) and GE Healthcare. The trial will determine whether contrast-enhanced mammography improves breast cancer detection and reduce false-positive exams in women with dense breasts.

About 43 percent of women aged 40 to 72 have dense breasts, which can make detection of breast cancer more challenging when using mammography alone. The CMIST study seeks to determine if contrast-enhanced mammography (CEM) provides more accurate cancer detection compared to digital breast tomosynthesis (DBT) in women with dense breasts.

CEM combines mammography and vascular-based screening methods in a simple and quick procedure to highlight areas of unusual blood flow patterns that may indicate malignancy. Early studies of CEM in screening women with dense breasts have shown the potential benefit of CEM in the detection of breast cancer.

CMIST is designed for asymptomatic women 45-74 years old with dense breast tissue. 

• Patients with breast problems or complaints
• History of allergy to iodinated contrast
• Decreased kidney function
• Above average risk of breast cancer
• History or breast cancer
• History of atypical tissue on prior biopsy
• Patients who have had prior contrast mammography in the past 3 years or screening breast ultrasound or breast MRI in the past 1 year.

Yes. Your provider can request a CESM at CBIS. CESM is currently approved as a “problem solving” tool when routine mammography and ultrasound are inconclusive. Other uses do not fall under the formal FDA approval. MRI is typically used for advanced imaging (new breast cancer diagnosis, high risk screening) but if MRI is not possible or not desired, CESM has been used as an alternative.

This is a multi center trial with up to 15 sites in North America (USA and Canada). At the present time, Carolina Breast Imaging Specialists is the first and only site that is actively enrolling patients.

This study requires a routine screening DBT (tomosynthesis/3D mammogram). This is typically covered but will be billed to insurance as usual.  The contrast mammogram is paid by the study sponsor and will not be billed to the patient or their insurance company. If an abnormality is found on either the contrast mammogram OR the routine “3D” mammogram, any needed additional evaluation with ultrasound or mammography is billed to insurance as usual and the patient may be responsible for copay/deductible.

• Eligibility is confirmed 
• Informed consent is obtained.

• Day 1

1. 1. Routine 3D Tomosynthesis mammogram is performed
   2. IV is placed and contrast material injected
   3. Contrast mammogram is performed (just 2 more pictures per side)
   4. The Tomosynthesis exam and Contrast exam are reviewed independently by 2 radiolgists (each reading one of the components)
   5. Any abnormalities found on either exam are evaluated further as needed with mammography and/or ultrasound
   6. Suspicious abnormalities will be biopsied on a different day.

• One year after enrollment

1. 1. Same protocol as day 1

• Year 2

1. 1. Routine screening tomosynthesis WITHOUT contrast mammogram.
   2. The results of this exam are part of the study data

No. Any patient eligible for screening mammography can participate (if eligible for CMIST). No order is needed for the screening or for the study. As usual, we will need to obtain permission from your provider to evaluate any abnormalities found on any imaging exam. We will attempt to obtain that before your exam.

Please email: info@cbispecialists.com

or 

Call: 252.565.8951