Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

High risk patients will get standard of care screening MRI and study CESM on the same day.

High risk screening MRI will be performed as part of the patient's routine care.

After the MRI is complete, the patient will be brought to the mammography department for the contrast enhanced mammogram. The contrast enhanced mammogram will be independently interpreted by two study radiologists (randomly assigned) who are blinded to the MRI. They will then compare to the MRI to determine clinical follow-up. Any finding seen on MRI will be followed according to the MR protocol. Any finding seen on CESM only, will have a diagnostic work-up with mammography and ultrasound. If this work-up is negative, then follow-up CESM exams will be performed. Each patient will be followed for 2 years to determine sensitivity and specificity for both modalities.

CESM

Jordana Phillips, MD

This research study is comparing Dual-Energy Contrast-Enhanced Spectral Mammography (CESM) to MRI as a screening tool for breast cancer.

This research study is being done to test how well a contrast enhanced mammogram compares to MRI in screening for breast cancer in people who are at higher risk for developing breast cancer.

Standard screening mammograms can miss breast cancers due to its inability to "see through" dense breast tissue. For this reason, women at increased risk for the development of breast cancer often undergo additional screening beyond conventional mammography with magnetic resonance imaging (MRI). Although screening MRI is very sensitive for finding breast cancer, it also finds many areas that are benign (not cancer). The only way to know which is the cancer is to perform a biopsy, which contributes to patient anxiety and leads to many unnecessary biopsies.

In the preliminary studies performed in women already diagnosed with breast cancer, contrast enhanced mammography was shown to have a similar sensitivity for finding primary breast cancer but detected fewer of the benign findings which would result in fewer unnecessary biopsies. It is also a faster and less expensive exam compared to MRI. Contrast mammography was FDA approved in 2011 and is used now as a tool to help work-up abnormalities seen on standard mammography and ultrasound.

We are now studying to see if contrast enhanced mammography will also be a beneficial tool in the screening setting to screen high risk patients for breast cancer.

Comparison of Contrast-enhanced Spectral Mammography (CESM) to MRI in Screening High Risk Women for Breast Cancer

Dual-energy Contrast-enhanced Digital Subtraction Mammography (CESM) as a Tool to Screen High Risk Women for Breast Cancer: a Comparison to Screening Breast MRI

All CESM and MRI cases will be evaluated for the presence or absence of malignancy and will be coded to reflect this interpretation. Breast imaging-reporting and data system (BIRADS) scores of 1-3 represent the absence of malignancy and BIRADS code of 4-5 represent the presence of malignancy. These cases will be compared to the truth of whether malignancy developed in the patient based on biopsy results and long term clinical follow-up (2 years).

GE Healthcare

Beth Israel Deaconess Medical Center

Principal Investigator

Control arm, no supplementary imaging is given. Participants have mammographic screening 3-yearly as per current standard of are.

Supplementary imaging with abbreviated MRI at study entry and 18 months after baseline mammogram.

Supplementary imaging with automated breast ultrasound at study entry and 18 months after baseline mammogram.

Supplementary imaging with contrast enhanced spectral mammography at study entry and 18 months after baseline mammogram.

Automated whole breast ultrasound (ABUS) is undertaken with a large transducer panel placed on the breast in three positions. Resultant images are combined to make a 3D image of the breast.

ABUS

A high kV and a low kV image is taken in two standard views of each breast following the intravenous injection of an iodinated contrast agent.

ABB-MRI is a shorter version of breast MRI. Standard T1W pre and post contrast images are acquired. A MIP and post-contrast T1 weighted image are read.

ABB-MRI

Fiona Gilbert

Jaimie Taylor

Reena Aggarwal

Jonathan James

Sarah Vinnicombe

Sarah Savaridas

Archana Seth

Nisha Sharma

Tamara Suaris

William Teh

Anthony Maxwell

BRAID is a randomised, multi-centre study assessing the impact of supplementary imaging in the detection of breast cancer in women participating in the UK national breast screening programme who have dense breast tissue.

Breast density is a measure of the amount of fibroglandular tissue and is a risk factor for breast cancer. Women with extremely dense breasts are at 4-fold increased breast cancer risk compared to women with 'fatty' breasts. High breast density reduces the sensitivity of mammography increasing the probability of the test missing a cancer. Women with dense breasts have their cancers found when the cancer is larger as they present with interval cancers or their cancers are not detected until the next screening round at a later stage.

The UK national breast screening programme (NHS BSP) offers all women aged 50-70 screening with 3-yearly mammograms. It aims to reduce breast cancer mortality by 20% by detecting small cancers thereby reducing the number of late stage diagnoses. However only 53% of the cancers being detected are small (\<15mm). This is partly due to masking of cancers by dense breast tissue.

This trial addresses how best to screen women with dense breasts for breast cancer. BRAID will randomise women whose recent screening mammogram shows that they have dense breasts to either standard of care (no supplementary imaging) or supplementary imaging with abbreviated MRI (ABB-MRI), automated whole breast ultrasound (ABUS) or contrast enhanced spectral mammography (CESM). These imaging techniques have been shown to be more sensitive than mammography at detecting cancers in dense breast tissue. Our hypothesis is that more cancers will be detected at an earlier stage with supplemental imaging.

Breast Screening - Risk Adaptive Imaging for Density

All cancers (detected or interval) in each arm over a three year period will be collected.

size, lymph node status, metastatic status

Analysis will include: Detection rate of all breast cancers, Detection rate of all breast cancers by stage; Detection rate of all breast cancers by biological type; Detection rate of all breast cancers by size; Recall rates at prevalent round

Analysis will include: Detection rate of all breast cancers, Detection rate of all breast cancers by stage; Detection rate of all breast cancers by biological type; Detection rate of all breast cancers by size; Recall rates

Analysis will include: Detection rate of all breast cancers, Detection rate of all breast cancers by stage; Detection rate of all breast cancers by biological type; Detection rate of all breast cancers by size; Recall rates at incident round; Interval cancer rate; Stage of interval cancers; Size of interval cancers

Average time and range for each modality. (Seconds).

Percentage 5 year risk, percentage lifetime risk.

Cancer Research UK

Queen Mary University of London

Public Health England

University of Cambridge

Professor of Radiology and Head of Department

Each enrolled participant will receive both a CESM and MRI exam prior to the breast biopsy, if they had not been performed already as part of clinical care.

MRI: Breast MRI will be performed, if not already performed as part of clinical care.

CESM: After the MRI is complete, patients will be brought to the mammography department for the contrast enhanced mammogram. The CESM will only occur if not already performed as part of the patient's clinical care.

Biopsy: Patients will then have their biopsy. Any additional findings seen on the CESM or MRI will be worked up also.

Reader Study: The CESM and the MRI images will be included in a case set that is ready by 10 study radiologists at a later date, after the biopsy is performed. These radiologists will look at the images to see if CESM and MRI find the same number of breast cancers.

Contrast enhanced mammography is a new type of mammogram. It uses contrast material combined with the mammogram to highlight areas that might be breast cancer and that could be missed on the mammogram alone

MRI uses magnets to create a detailed image of the tissues and bones inside of the body

Vandana Dialani, MD

This research study is evaluating whether contrast enhanced mammography can be used as an alternative to breast Magnetic Resonance Imaging (MRI) for cancer screening

Mammography is the main way to help find breast cancers early so they can be treated. Unfortunately, mammography does not work as well in women who have dense breast tissue or who are at high-risk for breast cancer. In these women, breast MRI is also used to help find breast cancers.

Contrast enhanced mammography is a new type of mammogram. It uses contrast material combined with the mammogram to highlight areas that might be breast cancer and that could be missed on the mammogram alone. This is similar to breast MRI.

For this study, participants who are already getting a breast biopsy will have a contrast enhanced mammogram and a breast MRI before the biopsy. The participant's contrast enhanced mammogram and breast MRI images will then be included within a large collection of images. Radiologists will compare the images to see if the contrast enhanced mammograms and the breast MRI find the same number of breast cancers. If the investigators find they perform similarly, then contrast mammography may be used to aid in breast cancer screening in the future.

Contrast Enhanced Spectral Mammography vs. MRI for Breast Cancer Screening

We will determine whether CESM is non-inferior to breast MRI for breast cancer detection by comparing cancer detection rates on both studies using a multi-case multi-reader study model.

We will determine whether CESM is non-inferior to abbreviated breast MRI for breast cancer detection by comparing cancer detection rates on both studies using a multi-case multi-reader study model.

We will determine whether CESM is superior to conventional 2D mammographic screening using a multi-case multi-reader study model.

We will provide each patient with a survey following completing of the CESM and MRI exams to understand which exam the patients prefer for breast cancer screening

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparison of Contrast-enhanced Spectral Mammography (CESM) to MRI in Screening High Risk Women for Breast Cancer	NCT02275871	Breast Cancer	MRI CESM	30 Years -	Dana-Farber Cancer Institute
Breast Screening - Risk Adaptive Imaging for Density	NCT04097366	Breast Cancer	ABUS CESM ABB-MRI	50 Years - 70 Years	University of Cambridge
Contrast Enhanced Spectral Mammography vs. MRI for Breast Cancer Screening	NCT03482557	Breast Cancer	CESM MRI	30 Years - 110 Years	Beth Israel Deaconess Medical Center

Spots Global Cancer Trial Database for cesm

Every month we try and update this database with for cesm cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for cesm

Every month we try and update this database with for cesm cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for cesm cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.