Active not recruitingPHASE3INTERVENTIONAL

Digital Tomosynthesis Mammography and Digital Mammography in Screening Patients for Breast Cancer

This study is looking at two different ways to check for breast cancer: regular digital mammograms and a newer, 3D type of mammogram called digital tomosynthesis. Researchers want to find out if the 3D mammogram is more effective at detecting breast cancer compared to the standard method. They also hope it might help reduce the number of times women are called back for extra tests or treatments. This is a large study at a late stage of research (Phase 3), focusing on women aged 45 to 74 who are due for a routine breast screening. The goal is to improve how we screen for breast cancer, making it more accurate and less stressful for patients.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

ECOG-ACRIN Cancer Research Group

Enrolment target

108,508

Start

28 Sep 2017

Estimated completion

31 Dec 2030

Breast Screening

What is this study about?

This research study is about finding the best way to screen for breast cancer. When you go for a breast screening, you usually receive a test called a mammogram, which is a special type of X-ray. In this study, doctors are comparing two kinds of mammograms: the regular digital mammogram you might be familiar with, and a newer, more advanced type called digital tomosynthesis mammography. Think of it like taking a regular flat photo versus a series of photos that can be put together to make a 3D image – the tomosynthesis gives doctors a more detailed, 3D view of the breast tissue.

The main aim of the study is to see if this 3D mammogram is better at finding breast cancer, especially more serious cancers, over a period of about four and a half years. They also want to know if it can help reduce the number of times women are called back for more tests after their initial screening, which can be a worrying experience. By comparing these two methods, the researchers hope to make breast cancer screening more accurate and efficient in the future.

Ultimately, this research could change how breast cancer screening is done, leading to earlier detection of cancer and potentially fewer unnecessary procedures for women. It's a big step towards improving breast health and care for everyone.

Key takeaways

Compares standard 2D mammograms with newer 3D mammograms.
Aims to find out if 3D mammograms are better at detecting breast cancer.
Hopes to reduce the need for extra tests after screening.
Open to women aged 45-74 without current breast symptoms.
Participation involves following up on your health for about 4.5 years.
Your involvement could help improve future breast cancer screening for everyone.

Who may be eligible?

This study is looking for women aged between 45 and 74 who are planning to have a routine breast screening. You can't have any existing symptoms of breast problems, like a lump or discharge, that would require immediate check-ups.

You also can't have had a breast screening in the last 11 months, and you shouldn't have a personal history of breast cancer. If you have breast implants or injections, you won't be able to join. The study also has some specific requirements for women depending on their menopausal status and other risk factors like breast density, family history, or if they are taking hormone therapy.

It's important that you are not pregnant or breastfeeding. You must also be able to comfortably have both types of mammogram tests and be willing to give your written permission to take part.

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 a woman between 45 and 74 years old?
Are you planning to have a routine breast screening soon?
Do you currently have no symptoms like a breast lump or nipple discharge?
Have you not had a screening mammogram in the last 11 months?
Do you have no personal history of breast cancer?
Are you not pregnant or breastfeeding and do not have breast implants?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be randomly assigned to receive either the standard digital mammogram or the digital tomosynthesis mammogram for your breast screening. This means you won't get to choose which type you receive. Both procedures are similar to a regular mammogram, where your breast is gently pressed between two plates to take X-ray images.

Researchers will collect information about your health and medical history, including details about your age, menopausal status, and family history. They will then follow your health for about four and a half years after your initial screening. This follow-up helps them see if there are any differences in how well each screening method works over time, such as detecting cancer or preventing the need for further tests.

Potential risks and benefits

Participating in this study might offer the benefit of potentially detecting breast cancer earlier, especially if the new 3D mammogram proves more effective. You would also be contributing to important research that could improve breast cancer screening for many women in the future. As with any mammogram, there's a small exposure to radiation, and there's always a chance of false alarms, where initial findings might suggest a problem that turns out to be nothing serious, leading to temporary worry and additional tests. You are free to withdraw from the study at any time without affecting your medical care.

Locations (149)

University of Alabama at Birmingham Cancer Center
Verified postcode
Birmingham, United States
Mobile Infirmary Medical Center
Verified postcode
Mobile, United States
Banner-University Medical Center Phoenix
Verified postcode
Phoenix, United States
University of Arizona College of Medicine Phoenix
Verified postcode
Phoenix, United States
Valleywise Comprehensive Health Center - Phoenix
Verified postcode
Phoenix, United States
Mayo Clinic Hospital in Arizona
Verified postcode
Phoenix, United States
Scottsdale Medical Imaging Limited
Verified postcode
Scottsdale, United States
University of Arkansas for Medical Sciences
Verified postcode
Little Rock, United States
Kern Radiology Medical Group Inc
Verified postcode
Bakersfield, United States
Los Angeles General Medical Center
Verified postcode
Los Angeles, United States
USC / Norris Comprehensive Cancer Center
Verified postcode
Los Angeles, United States
Kaiser Permanente-Modesto
Verified postcode
Modesto, United States

Common questions

What is the difference between the two mammograms?

One is a standard 2D X-ray, and the other (tomosynthesis) is a more detailed 3D X-ray of your breast.

Why is this study important?

It helps researchers find out if the newer 3D mammogram is better at finding breast cancer and reducing stress for patients.

Will I know which type of mammogram I'm getting?

You will be randomly assigned to either the standard or 3D mammogram; you won't get to choose.

How long will I be involved in the study?

The study will follow your health for about four and a half years after your initial screening.

What if I get called back for more tests?

Getting called back is a possibility with any breast screening. The study is trying to understand if one method reduces these call-backs.