Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Women without a history of breast cancer undergoing screening digital mammography, screening digital breast tomosynthesis, or screening breast magnetic resonance imaging.

Women diagnosed with stage 0-III breast cancer undergoing pre-operative work-up with diagnostic mammography alone or diagnostic mammography plus pre-operative breast magnetic resonance imaging.

Screening digital mammography

Screening with digital mammography plus digital breast tomosynthesis

Screening digital breast tomosynthesis

Screening with digital mammography plus breast magnetic resonance imaging

Screening breast magnetic resonance imaging

Pre-operative diagnostic work-up with mammography alone

Diagnostic mammography

Pre-operative diagnostic work-up with mammography plus breast magnetic resonance imaging

Pre-operative breast magnetic resonance imaging

Diana L Miglioretti, PhD

This Breast Cancer Surveillance Consortium (BCSC) ADVANCE study is a large, observational pragmatic comparative effectiveness research study using high-quality, prospectively collected data from BCSC registries to generate evidence on how breast density should be integrated into decision making around breast cancer screening and preoperative diagnostic work-up. We will augment existing BCSC registry infrastructure with additional prospective data collection and collection of patient reported outcomes (PROs), CISNET modeling of long-term screening outcomes, and qualitative data from focus groups with women represented in two aims.

Aim 1: Compare the effectiveness of breast cancer screening using digital mammography alone versus digital mammography plus supplemental screening (digital breast tomosynthesis or MRI) by extent of breast density.

Sub aim 1: Evaluate whether the performance of tomosynthesis improves with years of experience, and whether any "learning curve" depends on radiologist specialty (i.e., breast imaging specialist vs. general radiologist).

Aim 2: Compare the effectiveness of preoperative MRI versus no MRI by extent of breast density among women with an initial, pathologically confirmed diagnosis of DCIS or invasive breast cancer.

Covid-19 Enhancement Aim and Hypotheses:

Develop patient-focused messaging content through focus groups that radiology facilities can use when scheduling appointments to inform women of the safety to schedule or postpone breast screening or diagnostic services.

Assessing Breast Density's Value in Imaging - A Comparative Effectiveness Study

Comparative Effectiveness of Breast Cancer Screening and Diagnostic Evaluation by Extent of Breast Density

Please visit http://www.bcsc-research.org for information about requesting BCSC data.

Breast cancers deaths averted estimated by the Cancer Intervention and Surveillance Modeling Network (CISNET) models

Life-years gained estimated by the Cancer Intervention and Surveillance Modeling Network (CISNET) models

Overdiagnosis estimated by the Cancer Intervention and Surveillance Modeling Network (CISNET) models

Number of stage I or IIA cancers diagnosed within 1 year of a positive screen divided by total number of screens

Number of invasive cancer cases within 1 year of a negative screen divided by total number of screens

Number of advanced cancers (stage IIB or higher) within 1 year of a screen divided by total number of screens

Number of positive screens divided by total number of screens

Number of positive screens without a cancer diagnosed within 1 year divided by total number of screens

Number of screens with a biopsy recommendation and no cancer diagnosed within 1 year divided by total number of screens

Number of DCIS diagnoses within 1 year of a positive screen divided by total number of screens, reported overall and by grade

Patient surveys targeted to determining outcomes of interest to patients

Number of women with contralateral breast cancer diagnosed within 6 months of initial diagnosis over total number of women

Rate of 2nd breast cancers diagnosed within 3 years of follow-up (starting 6 months after initial diagnosis) calculated separately for ipsilateral and contralateral cancers

Number of cancer cases within 1 year of positive screen divided by number of breast cancer cases

Number of negative screens without cancer diagnosed within 1 year of screen divided by number of screens without breast cancer

Number of cancer cases within 1 year of positive screen divided by number of positive screens

Rates of unilateral mastectomy, or bilateral mastectomy, lumpectomy with reconstruction, lumpectomy without reconstruction

Number of women with a negative pre-operative MRI and no additional cancers diagnosed within 6 months after initial diagnosis over the total number of women with a negative pre-operative MRI

Number of women without a pre-operative MRI with no additional cancers diagnosed within 6 months after initial diagnosis over the total number of women without a pre-operative MRI

Number of core biopsies within 6 months of initial diagnosis over number of breast biopsies

Number of surgical biopsies within 6 months of initial diagnosis over number of breast biopsies

Number of initial benign biopsies over number of breast biopsies

Patient-Centered Outcomes Research Institute

University of California, San Francisco

Dartmouth College

Kaiser Permanente

University of Vermont

University of North Carolina

University of Illinois at Chicago

Advocate Health Care

Harvard Pilgrim Health Care

Albert Einstein College of Medicine

Erasmus Medical Center

University of California, Davis

Phase Contrast Mammography

Etta D Pisano, MD

To determine if diagnostic phase contrast mammography (PCM) will provide improved image detail in assessing lesion characteristics when compared to diagnostic x-ray mammography (XM).

The ability to detect lesions in mammography before they can be felt is the benefit of using this imaging modality for screening of breast cancer. Screening mammography has been proven to decrease mortality from breast cancer. Radiologists identify abnormal breast tissue in the form of microcalcifications, masses, architectural distortion, and asymmetric density by careful assessment of the characteristics of these types of lesions using the Breast Imaging Reporting and Diagnostic System (BIRADS). BIRADS was developed to provide standardization of reporting of mammographic exams. In screening mammography, while it is possible to detect lesions, often more detailed diagnostic imaging is necessary to improve the visibility of margins and edges of lesions through magnification and compression views of the lesion of interest due to spatial resolution limitations which causes geometric blurring of edges in x-ray mammography.

If the ability to clearly see margins and edges of lesions is possible at screening mammography, this would potentially decrease the overall radiation exposure currently needed to allow radiologists to be confident of their characterizations for the majority of patients using x-ray mammography. Digital mammography was developed to improve the visibility of lesions primarily in dense breasts. The reasoning was that the improved contrast range would allow for wider range of gray level differentiation but with digital mammography comes a spatial resolution limitation that blurred edges of lesions. Phase contrast mammography (PCM) was developed to improve digital mammography by providing improvement in sharpness of edges utilizing the x-ray properties of refraction.

Comparison: Phase Contrast Mammography to X-Ray Mammography for Lesion Visibility of Diagnostic Population

Visibility of Lesion Characteristics With Phase Contrast Mammography

Lesion Characteristics' Visibility With Phase Contrast Mammography in Comparison to X-Ray Mammography for Women Undergoing X-Ray Diagnostic Mammography

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Assessing Breast Density's Value in Imaging - A Comparative Effectiveness Study	NCT02980848	Breast Cancer	Screening digit... Screening digit... Screening breas... Diagnostic mamm... Pre-operative b...	18 Years - 89 Years	University of California, Davis
Visibility of Lesion Characteristics With Phase Contrast Mammography	NCT00467727	Breast Cancer	Phase Contrast ...	40 Years -	UNC Lineberger Comprehensive Cancer Center

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