Clinical Trials

The purpose of this study is to examine behavioral and psychological outcomes of breast density notification using a 3-group randomized design comparing usual written notification to two educationally-enhanced approaches.

The purpose of this study is the creation of a long-term prospective observational study of women undergoing screening mammography at Mayo Clinic. The cohort will be used to evaluate risk models for breast cancer incorporating epidemiological risk factors, genetic risk factors, breast density measures, imaging data, results from diagnostic tissue biopsies, and liquid biopsy assays. The cohort will also be useful for clinical validation and assessment of clinical utility of predictive and prognostic biomarkers for breast cancer.

This research study is being done to determine if a low vitamin D level and mammographic density may be risk factors for developing breast cancer.

This randomized phase II trial studies how well abbreviated breast magnetic resonance imaging (MRI) and digital tomosynthesis mammography work in detecting cancer in women with dense breast. Abbreviated breast MRI is a low cost procedure in which radio waves and a powerful magnet linked to a computer and used to create detailed pictures of the breast in less than 10 minutes. These pictures can show the difference between normal and diseased tissue. Digital tomosynthesis mammography is a procedure that uses multiple x-rays pictures of each breast to produce a 3-dimensional rendering of the entire breast. Combined screening with abbreviated breast ...

The primary purpose of this study is to evaluate the incremental invasive cancer yield in patients with a negative mammogram who are intermediate or high-risk for breast cancer and get supplemental screening with Contrast-Enhanced Digital Mammography (CEDM).

The goal of this project is to develop an AI system for early cancer detection on routine screening tomosynthesis mammograms. There will be significant impact on clinical practices if a mammography AI tool can be built. Such a tool will improve efficiency and decrease false positives and false negatives in practice. 

This protocol captures the details for the reader study involving Aidoc, ScreenPoint, and iCAD. Mayo Clinic Breast Imaging Radiologists will evaluate the software tools that both ScreenPoint  and iCAD have developed for assisting in reading tomosynthesis scans. Aidoc is facilitating this study by providing their user ...

The purpose of this study is to help women in their late 30s and in their 40s, make decisions regarding breast cancer screening that align with each women’s values and preferences. 

The significance of this study is that it will be the first prospective trial to compare MBI, a relatively low-cost functional breast imaging technique, to DBT, the new standard anatomic breast cancer screening technique in women with dense breasts. This study is also the first to evaluate two consecutive annual MBI scans to assess change in advanced cancer presentation after introduction of a functional imaging technique. These data will inform individualized decisions on supplemental screening and determine if a functional technique that is relatively low in cost and complexity of interpretation can eliminate the reservoir of clinically important breast cancers ...

The purpose of this study is to evaluate digital tomosynthesis (3-D) mammography and digital mammography in screening patients for breast cancer. Screening for breast cancer with tomosynthesis mammography may be superior to digital mammography for breast cancer screening and may help reduce the need for additional imaging or treatment.

The purpose of this study is to obtain additional high resolution images of your breast cancer using a Positron Emission Mammography (PEM) system. This system only allows us to image the breast, but provides higher quality and better resolution than those images we obtain with the PET/CT scanner.

The purpose of this study is to understand the causes of breast cancer, in particular the connection between genetic variations and breast density or how tissue is distributed on a mammogram.

The purpose of this study is to evaluate the accuracy of diagnosis with contrast enhanced digital mammography when used in addition to standard mammography or ultrasound in patients with suspicious findings.

The purpose of this study is to determine whether contrast-enhanced ultrasound (CEUS) can be used in diagnostic evaluation of breast lesions that cannot be seen using contrast-enhanced MRI (CEMR) and contrast- enhanced dual energy mammography (CEDM).   If so, patients can undergo US guided biopsy which is more comfortable for patients and more cost effective.

The goal of this research is to identify risk profiles of women (with particular emphasis on Hispanic women) for breast cancer based on family history, breast density and other factors known to impact risk such as age, weight, age at menarche, age at birth of first child, etc.

The purpose of this study is to evaluate if changes made to the design of the table used specifically for breast Positron Emission Mammography (PEM), will help improve the images of breast tissue close to the chest wall.

The purpose of this study is to assess whether patients undergoing a breast MRI (magnetic resonance imaging) before breast surgery will have better results after the surgery. Breast tumors are routinely evaluated using mammograms and ultrasound before surgery. This study would like to find out if using MRI in addition to mammography before surgery improves the ability to evaluate tumors and decide what kind of surgery is best for the patient.

Researchers are trying to learn more about the prevalence of genetic mutations in women who are at intermediate/high risk of breast cancer and how that information my assist providers in improving screening and preventative options.

This study proposes to combine data from six large existing epidemiology studies to examine the association of MD and clinical risk factors with breast cancer subtypes. 

The purpose of this study is to gather qualitative information about patient comfort during MBI examinations. The primary aim is to assess patient comfort during MBI, relative to comfort during a mammogram. We also wish to identify factors that contribute to discomfort and patients’ willingness to have MBI in the future.

The primary objective of this study is to determine the correlation between the distribution of F-18 FES within ER+ breast tumors as seen on Positron Emission Mammography (PEM) images of the breast, and the distribution of cells stained ER+ within the tumor by immunohistochemistry (IHC) measurements at surgical pathology. The secondary aim is to determine if the correlation (or lack of) between F-18 FES uptake and F-18 FDG uptake as imaged by PEM, is an accurate representation of the heterogeneity of ER expression in the tumor.

The objective of this study is to determine if the diagnostic performance of a dedicated breast-specific positron emission mammography (PEM) system, is superior to that obtained with a conventional PET/CT scanner and capable of producing acceptable image quality at a low-radiation dose level.

The no show rate for mammography screening is high among Navajo women. One barrier to preventive screening is a lack of cancer literacy including low knowledge and cultural attitudes (e.g., fatalism) about screening. The investigators will examine the potential feasibility and acceptability of a cancer literacy intervention for families of Navajo women who have no showed for three consecutive times to mammography screening who have never or rarely been screened in the past.

The purpose of this study is to develop a breast cancer survivor (BCS) multiscale omics database that includes a complete fecal metagenome (gut microbiome) and fecal metabolome characterization. 

Increased mammographic density is recognized as an important risk factor for developing breast cancer, however, the underlying mechanism explaining this relationship is unclear. The investigators hypothesize that Molecular Breast Imaging (MBI) can more accurately distinguish dense tissue on mammography which is at high risk from dense tissue at low risk by indicating cellular activity in dense tissue as radiotracer uptake (functional density) in the breast. In this pilot study, the investigators want to compare the histological characteristics of breast tissue in patients with who have similar density on mammography but different levels of functional density on MBI.

The investigators hypothesize that knowledge of the functional behavior of areas of mammographic density will enable more specific identification of dense tissue at-risk for breast cancer, ultimately providing predictive information on an individual's risk of developing breast cancer.

The purpose of this study is to evaluate a low-cost Contrast Enhanced Digital Mammogram (CEDM) protocol as a supplemental screening method to standard mammographic screening in women at intermediate lifetime-risk (and not undergoing annual MR surveillance) for breast cancer.