RecruitingNAINTERVENTIONAL

Comparison of Breast Cancer Screening With CESM to DBT in Women With Dense Breasts

This research, called CMIST, aims to find the best way to screen for breast cancer in women whose breasts appear dense on mammograms. Dense breasts can make it harder to spot cancer using standard mammograms, so doctors are always looking for better options. We are comparing two advanced imaging methods: Dual-Energy Contrast-Enhanced Spectral Mammography (CESM) and Digital Breast Tomosynthesis (DBT). The study wants to see if CESM can find more cancers and give fewer false alarms than DBT when used for regular breast screening. Taking part involves having both scans over a couple of years, with follow-up to see how effective they are. This could help improve future breast cancer screening for many women.

At a glance

Status

Recruiting

Phase

Sponsor

American College of Radiology

Enrolment target

2,032

Start

24 Mar 2023

Estimated completion

31 Jul 2027

Breast Cancer

What is this study about?

This important study, known as CMIST, is all about improving how we spot breast cancer early in women who have what's called 'dense breasts'. Dense breasts are quite common, and they can make it harder for doctors to see potential cancers on a regular mammogram. Because of this, it's really important to find even better ways to check these women for cancer.

The main goal of this research is to compare two different types of breast scans: Dual-Energy Contrast-Enhanced Spectral Mammography (CESM) and Digital Breast Tomosynthesis (DBT). Researchers want to find out if CESM is better at finding cancers and also reduces the number of 'false alarms' – which is when a scan suggests there might be a problem, but it turns out there isn't. If CESM proves to be more accurate, it could change how breast cancer screening is done for many women in the future.

We'll be looking at how well both CESM and DBT perform during an initial scan and then again one year later. By comparing the results, we hope to understand which method is more effective and reassuring for women with dense breasts. This type of research is crucial for making sure that breast cancer is detected as early as possible.

Key takeaways

This study compares two advanced breast cancer screening methods (CESM and DBT).
It aims to find the best screening method for women with dense breasts.
Participation involves two sets of scans over a year, plus a follow-up call.
You must be 45-74, have dense breasts, and no pregnancy or serious allergies to iodine dye.
Your involvement could help improve future breast cancer screening for many women.
You can stop participating at any time.

Who may be eligible?

This study is looking for women aged between 45 and 74 years old who have dense breasts. You'll know if you have dense breasts because it would have been noted on your most recent mammogram.

To join, you shouldn't have any current breast cancer symptoms like a lump or nipple discharge. You also need to be able to have an iodine-based dye injected into your veins, as this is part of the CESM scan. This means you shouldn't have any severe allergies to iodine or certain other substances. If you could be pregnant or are breastfeeding, this study would not be suitable for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 45 and 74 years old?
Do you have dense breasts (as noted on a previous mammogram)?
Do you currently have any breast symptoms like a lump or nipple discharge?
Are you able to have an injection of iodine dye?
Could you be pregnant or are you breastfeeding?
Are you currently having treatment for breast cancer?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be involved for about two years. At the very beginning, you'll have both a standard DBT scan and a CESM scan on the same day. This will happen within 30 days of officially joining the study. These scans will be done before any further tests, if needed.

About one year later, you'll come back for another visit. Just like the first time, you'll have both the DBT and CESM scans on the same day. These will also be done before any further tests. Between the first and second year, you should not have any other whole breast screening ultrasounds.

Roughly a year after your second visit (so, two years after you started), the study team will contact you. They'll get in touch by email, text, or phone call to check in and see if you've been diagnosed with breast cancer since your last scan. If you have been diagnosed with breast cancer in that time, you won't need to have any further scans for the study. The study team will also ask if you've had any unexpected or serious health issues, but in a way that doesn't lead you to say 'yes' or 'no'.

Potential risks and benefits

Taking part could help improve breast cancer screening for yourself and many other women in the future. You will also receive advanced breast screenings that might detect cancers earlier. Potential risks are generally small, such as mild discomfort from the scans or the iodine dye injection. There's also the chance of finding something that isn't cancer (a false alarm), which can cause worry and might lead to further tests. Remember, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (11)

University of Alabama, Birmingham
Verified postcode
Birmingham, United States· Recruiting
Boca Raton Regional Hospital - Christine E. Lynn Women's Health and Wellness Institute
Verified postcode
Boca Raton, United States· Recruiting
Lake Medical Imaging
Verified postcode
The Villages, United States· Active not recruiting
Boston Breast Diagnostic Center
Verified postcode
Wellesley Hills, United States· Recruiting
Henry Ford Health
Verified postcode
Detroit, United States· Recruiting
Memorial Sloan Kettering Cancer Center
Verified postcode
New York, United States· Recruiting
Carolina Breast Imaging Specialists
Verified postcode
Greenville, United States· Recruiting
Thomas Jefferson University Hospital
Verified postcode
Philadelphia, United States· Recruiting
The University of Texas MD Anderson Cancer Center
Verified postcode
Houston, United States· Recruiting
University of Virginia
Verified postcode
Charlottesville, United States· Recruiting
St. Joseph's Hospital
Verified postcode
London, Canada· Recruiting

Common questions

What are 'dense breasts'?

Dense breasts have more fibrous and glandular tissue than fatty tissue, which can make it harder for standard mammograms to spot cancers.

What is CESM?

CESM stands for Dual-Energy Contrast-Enhanced Spectral Mammography. It's a special type of mammogram that uses a dye and different X-ray energies to make breast tumours stand out.

What is DBT?

DBT stands for Digital Breast Tomosynthesis. It's a 3D mammogram that takes multiple X-ray images from different angles to create a clearer picture of the breast.

Will I get my results?

The study summary implies you will receive the imaging as part of your routine care, but you should discuss specifically if and how you will get your personal scan results with the study team.

Is there any cost to me?

Clinical trials usually cover the costs of the study treatments and tests, but you should confirm this with the study team.

How to find out more

Christopher Comstock, MD

chc4050@med.cornell.edu 212-746-6000 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.