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C-MERIT Study

Breast cancer is the most frequently diagnosed non-skin cancer in women across the globe, with nearly 2.3 million new cases and 685,000 deaths in 2020 alone. No other cancer can compare with breast cancer in the number of productive years of life lost by women worldwide.

MD Anderson has launched several research studies that use a new technology called contrast-enhanced mammography (CEM) to find better and more customized ways of detecting breast cancer, especially when mammography has limitations, such as in women with dense breasts. We call this group of studies C-MERIT (Contrast MERIT), because these studies are a subgroup of a large ongoing MD Anderson research project called MERIT (Mammography, Early detection biomarkers, Risk assessment, Imaging Technologies.) The purpose of MERIT is to combine imaging, patient history and blood biomarker information to predict the individual risk of breast cancer development and to choose the best approach to its early detection for each woman.

Contrast Enhanced Mammography (CEM)

Digital mammography is currently the standard of care imaging for early cancer detection. However, mammography cannot detect all breast cancer, including some cancers in women who have dense breast tissues. In addition, mammography often cannot tell cancerous from non-cancerous lesions, which may lead to work-up and biopsies of findings that are not cancers.

CEM is one of the newest technologies available in breast imaging. It is a digital mammogram performed after IV injection of iodinated contrast material. As a result, CEM can provide not only the same information as mammography, but in addition, it can map tissue activity that can show cancers better. This principle is similar to the one used in breast MRI. In fact, CEM is proven to be similar in its diagnostic accuracy to breast MRI, which is currently the strongest tool in breast imaging. Yet CEM is faster, more convenient and much cheaper than MRI.

The iodinated contrast material used for CEM is identical to the one used for CT scans, but is different from the gadolinium based contrast used for MRI. That’s why CEM can be considered in women who are allergic to gadolinium, or cannot have MRI for any other reason. There is a small additional dose of radiation associated with CEM when compared to 2D mammography, but the dose is less than the commonly used 2D/3D combination imaging. CEM can also be used together with tomosynthesis (3D mammography) to further improve precision of the diagnosis.

You can participate!

You may be able to take part in a C-MERIT study if any of the following statements are true:

You have dense breasts as determined by your last mammogram.
You have bloody, brown, or clear water colored nipple discharge, especially if it keeps coming back and appears only on one side.
You have breast implants and were recently diagnosed with breast cancer but are not treated yet.
You have breast implants and had breast imaging findings that are highly suspicious for cancer.

If you take part in this study, you will be asked to sign an informed consent document and complete a questionnaire, have the CEM and injection of contrast (through a needle in your vein), and have blood collected. This may require two separate needle sticks.

How To Participate

Step 1: Clinic appointment

To participate in the study, you will need to schedule an appointment with one of the MD Anderson breast care clinics as outlined below. Please make sure you provide the correct email address and phone number when scheduling your appointment.

If you are scheduling your routine annual mammogram, please schedule an appointment at the MD Anderson Texas Medical Center. You can request an appointment online or call 1-855-894-0147.
If you have breast implants and have already been diagnosed with breast cancer, please schedule an appointment with the Multi-Team Breast Clinic in MD Anderson's Nellie B. Connally Breast Center. You can request an appointment online or call 855-894-0147.
If you have breast implants and are referred to MD Anderson for a highly suspicious finding on your breast imaging, please make an appointment with the Undiagnosed Breast Clinic. You can request an appointment online or call 713-745-8040.
If you are coming for evaluation of concerning nipple discharge, please make an appointment with the Undiagnosed Breast Clinic. You can request an appointment online or call 713-745-8040.

If you schedule your mammogram during research study hours (see our Frequently Asked Questions section for current hours), you will receive a link to sign up for the C-MERIT study via email or text message.

Step 2: Enroll in the C-MERIT Study

Please tell the scheduling staff and the clinic that you are interested in participating in the research CEM study called C-MERIT. You can also request information about the study by contacting the study research staff (meritinfo@mdanderson.org).

You need to enroll in the study before your CEM appointment can be scheduled. A research staff member will send you information by email and contact you by phone to complete the enrollment and consent for the study.

Step 3: Schedule the research CEM Appointment

After you enroll in the C-MERIT study, your CEM visit will be scheduled. The team will work to coordinate multiple clinic appointments at the Texas Medical Center as needed. Because the CEM and new patient appointments are available only on certain days, it may not be possible to have all your imaging and clinic appointments on the same day. Please note that having CEM may mean you will no longer need to have breast MRI and an MRI-guided biopsy, which may decrease the overall length of your imaging work-up.

Step 4: Visit the Texas Medical Center for your imaging appointments, which will incorporate C-MERIT CEM study

A typical C-MERIT study appointment takes about 1 hour and includes:

CEM (Contrast-Enhanced Mammography)

CEM is completed after IV contrast injection.

Iodinated contrast will be injected by IV into your arm for CEM. The contrast agent is the same that is used for computer tomography (CAT scans). Negative reactions to contrast are very rare. Study personnel will make sure it is safe for you to have contrast by asking you several questions and, if needed, doing a quick blood test to check your kidney function.

Radiologists will use the CEM images to decide if any biopsies are needed. You will have breast ultrasound as a part of your routine clinical care. You may require ultrasound-guided or stereotactic (mammography-guided) biopsies, which also will be done as part of your clinical care.

If some findings in your breast are seen best with CEM, you may need a CEM-guided biopsy, which will require a second visit at least 48 hours after your first CEM. The research study will cover the cost of the contrast agent required for CEM. You and/or your insurance company are responsible for standard-of-care imaging and procedures.

Survey

After the C-MERIT study appointment, you will be observed for 30 min to make sure you have no allergic reactions to the IV contrast. During this time, you will receive a separate short survey about your CEM experience, which will take 5-10 minutes to complete.

Questionnaire

During or after their C-MERIT study appointment, participants will fill out a questionnaire through a link to a secure website. Family history of cancer, diet and other health questions will be asked. The questionnaire will take approximately 15 to 25 minutes to complete.

Blood Collection

Participants will have 3 tablespoons of blood drawn (less than 10% of a typical blood donation). The blood will be processed and stored in the MD Anderson biobank and will be used to test for biomarkers of breast cancer. Biomarkers are found in the blood and may be related to risk of cancer. The test results are for research only and will not be placed in the medical records of participants.

For questions about this C-MERIT study, or if you are interested in participating, please e-mail the research team at meritinfo@mdanderson.org.

Appointment and Study Information

Parking information for study participants (Texas Medical Center)

The garage with the easiest access to the mammography clinic is the Mays Clinic/Duncan Building garage, near Entrance 5 (not valet) on Bertner Ave. After parking, go to the 5th floor of the Mays Clinic.

There is also valet parking available on the west side of the clinic on Richard J.V. Johnson Ave.

When you arrive to the clinic, please email our research staff at meritinfo@mdanderon.org

You can also call or text the research staff upon arrival at 713-792-4563.

Frequently Asked Questions

What is the meaning of the study name, C-MERIT?

C-MERIT is an acronym: Contrast-enhanced Mammography, Early detection biomarkers, Risk assessment, and Imaging Technologies.

What is contrast enhanced mammography (CEM)?

CEM is an FDA-approved advanced mammography technology that provides all the same information as mammography, but it also shows tissue activity and blood vessel distribution in your breast, similar to breast MRI. CEM may show any potential cancer sites better than standard mammography, but CEM requires IV placement and contrast injection. The CEM also adds a small additional dose of radiation (approximately 30%) over standard 2D mammography, but the dose is less than that of a combination of standard 3D mammography (tomosynthesis) and 2D mammography, which is usually used in clinic.

Who can have CEM?

Any woman who has breast problems or is diagnosed with breast cancer and has no contraindications for IV contrast injections can have CEM as a part of this study. CEM may replace or be used in addition to regular mammography.

How does CEM compare to breast MRI?

CEM uses X-rays like mammography, and MRI uses strong magnetic fields. Both CEM and MRI are looking for abnormal blood vessels in the breast that can be a sign of breast cancer. Different from MRI, CEM can also produce a mammogram image that can replace a standard mammogram.

What time can I schedule my C-MERIT research appointment?

Your research appointment including the CEM will be coordinated with your other clinic appointments. Because the CEM and new patient appointments are available only on certain days, it may not be possible to have all your imaging and clinic appointments on the same day.

Will I be able to fit the C-MERIT research appointment in between other clinic appointments at the Texas Medical Center?

Yes, our C-MERIT and clinic research staff will work to accommodate your MD Anderson appointment schedule.

I cannot provide blood samples. Can I still participate in the C-MERIT study?

Unfortunately, no. The study requires blood samples to pair with the imaging and questionnaire data from participants. However, you can still participate if you do not wish to complete some of the questions from the questionnaire.

I have been invited to participate in another research study. Can I also participate in the C-MERIT study?

Yes, most of the time you can participate in more than one research study. Please let the C-MERIT research staff know that you are participating in other studies so that they can make sure you are still eligible. The C-MERIT staff will also help to coordinate blood draws, if applicable.

Will I receive any of the data from this study?

You and your referring provider will receive the results of your CEM study. The data from the blood draw is for research purposes only and will not be provided to participants or placed in any medical records. However, the research data may be used to qualify participants for clinical trials or other research studies. In this case, participants will be notified by the C-MERIT staff via email or text message if they qualify for additional studies.