Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Contrast Enhanced Spectral Mammography

Introduction: To avoid unnecessary mastectomies and reoperations a correct size assessment of malignant lesions in breast is required. Sometimes a supplementary MRI is therefore recommended. However, at our unit MRI is not easily available. Contrast enhanced spectral mammography (CESM) has in smaller studies been shown to be equal to MRI regarding sensitivity and specificity. Size assessment using contrast-based modalities as CESM has also been shown to be significantly more accurate than using mammography. Prospective randomized studies using CESM are lacking.

Aim: The aim of the study is to evaluate the added value of CESM in diagnostics of breast cancer and choice of operation; partial mastectomy or mastectomy.

A pilot study of 50 patients will be conducted to prepare for a larger prospective randomized study.

Method: Patients found with breast cancer after diagnostics with mammography, ultrasound and core biopsy, and whom are recommended primary surgery, will be enrolled in the study. A supplementary examination with CESM will be performed. Preoperative extent of the malignant lesions are estimated with each modality and is later compared with the extent measured in post-operative PAD. Data on weight, length, age at menopaus, use of contraceptive pills, HRT or endocrine therapy, breast volume and density is collected, as well as data of diagnosis (ductal or lobular carcinoma), surrounding DCIS, histological grade, ER, PgR, Her2 expression and Ki67 index.

In this pilot study sensitivity and specificity for each modality is calculated. Multivariate analysis will be performed regarding influential factors. Pearson correlation coefficient will be calculated for each modality regarding size assessment of the malignant lesions in comparison with definitive PAD.

Most breast cancers occur in women. Male breast parenchyma is very small. Not suitable to examine by contrast enhanced spectral mammography in this study

Added Value of Contrast Enhanced Spectral Mammography, CESM. A Pilot Study.

Added Value of Contrast Enhanced Spectral Mammography, CESM in Diagnostics and Size Estimation of Malignant Lesions in Breast. A Pilot Study.

Mastectomy instead of partial mastectomy, neo-adjuvant chemotherapy instead of primary surgery

Region Skane

Patients will undergo an experimental Contrast Enhanced Spectral Mammogram (CESM) in addition to standard diagnostic procedures

Patient will follow standard care pathway.

Undergo a Contrast Enhanced Spectral Mammogram in additional to standard of care

Contrast Enhanced Spectral Mammogram

Fiona J Gilbert, FRCR

The aim of this study is to determine if the addition of Contrast Enhanced Spectral Mammography (CESM) to standard diagnostic imaging, results in a decision regarding patient management - discharge, follow-up, surgery or treatment - being made sooner than it would if the patient had followed the standard course of investigations and review.

Women with suspicious breast lesions following mammography and ultrasound will be eligible for the study. Those who consent to participate will be randomised either to receive Contrast Enhanced Spectral Mammography (CESM) in addition to standard care or to receive standard care alone.

Women randomised to receive CESM will undergo the procedure either during the same visit or if necessary on another date within a week. Any additional suspicious lesions detected by CESM will be biopsied along with the original lesion either under ultrasound or x-ray guidance. Biopsy of suspicious lesions is standard care and not part of the research protocol. Those randomised to receive standard care will undergo ultrasound or x-ray guided biopsy of any suspicious lesion identified by ultrasound or mammography.

Results of all biopsies will be discussed at the next multidisciplinary (MDT) meeting where a treatment decision (conservation surgery, mastectomy or neoadjuvent therapy) will be made for those with confirmed disease. MRI will be performed on appropriate women in line with standard practice. Additional disease detected by MRI will be biopsied, either under ultrasound or MRI guidance, if this will influence patient management. The results from these cases will be discussed at the next MDT meeting.

For those women in either arm of the study with benign biopsy results standard care will be followed.

A proforma will be used to record patient pathway, biopsy results and MDT patient management decisions for each case.

For women who received both CESM and MRI, a retrospective review of these images will be made in order to compare diagnostic accuracy. Images from each imaging modality will be read by a different reader for each case. CESM images will be read without the knowledge of MRI results and vice versa. A proforma will be completed by readers to record findings.

Contrast Enhanced Spectral Mammography (CESM) Study

An Assessment of the Impact of CONTrast ENhanceD Mammography (CESM) on Patient Management and Comparison With MRI (CONTEND Study)

The pathway of each participant through the diagnostic process will be reviewed at the end of the data collection period to assess whether the addition of CESM resulted in a definitive decision regarding treatment being made earlier than in the usual diagnostic route.

University of Cambridge

GE Healthcare

Cambridge University Hospitals NHS Foundation Trust

Professor of Radiology, Department Head

Breast Diseases

Skin Diseases

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

CESM

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
Added Value of Contrast Enhanced Spectral Mammography, CESM. A Pilot Study.	NCT03402529	Breast Cancer	Contrast Enhanc...	18 Years - 80 Years	Region Skane
Added Value of Contrast Enhanced Spectral Mammography, CESM. A Pilot Study.	NCT03402529	Breast Cancer	Contrast Enhanc...	18 Years - 80 Years	Region Skane
Contrast Enhanced Spectral Mammography (CESM) Study	NCT02479100	Breast Cancer	Contrast Enhanc...	18 Years - 85 Years	Cambridge University Hospitals NHS Foundation Trust
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 contrast enhanced spectral mammography