Assessing Breast Density's Value in Imaging - A Comparative Effectiveness Study
NCT ID: NCT02980848
Last Updated: 2021-11-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
1341172 participants
OBSERVATIONAL
2016-09-30
2022-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Screening group
Women without a history of breast cancer undergoing screening digital mammography, screening digital breast tomosynthesis, or screening breast magnetic resonance imaging.
Screening digital mammography
Screening with digital mammography alone
Screening digital breast tomosynthesis
Screening with digital mammography plus digital breast tomosynthesis
Screening breast magnetic resonance imaging
Screening with digital mammography plus breast magnetic resonance imaging
Women with breast cancer
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.
Diagnostic mammography
Pre-operative diagnostic work-up with mammography alone
Pre-operative breast magnetic resonance imaging
Pre-operative diagnostic work-up with mammography plus breast magnetic resonance imaging
Interventions
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Screening digital mammography
Screening with digital mammography alone
Screening digital breast tomosynthesis
Screening with digital mammography plus digital breast tomosynthesis
Screening breast magnetic resonance imaging
Screening with digital mammography plus breast magnetic resonance imaging
Diagnostic mammography
Pre-operative diagnostic work-up with mammography alone
Pre-operative breast magnetic resonance imaging
Pre-operative diagnostic work-up with mammography plus breast magnetic resonance imaging
Eligibility Criteria
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Inclusion Criteria
* Women aged 40-74 years undergoing screening mammography, with or without supplemental screening with digital breast tomosynthesis or breast MRI, at selected BCSC facilities
* Women within 12 months of a digital screening mammogram with known breast density and no known breast cancer diagnosis
* For MRI subgroup, we will include women with a screening MRI within the prior 24 months
* Within strata defined by BCSC registry, breast density subgroup (dense vs. not dense), and race/ethnicity, women with supplemental screening with digital breast tomosynthesis or breast MRI will be matched to women without supplemental screening
Aim 1 Focus Groups
* Women age 40-74 years undergoing screening mammography, with or without supplemental screening (defined as digital breast tomosynthesis or breast MRI)
* Women within 12 months post-most recent screening examination with known dense breasts from most recent screening mammogram and no known breast cancer diagnosis
* Women who are able to speak English and can travel to a nearby location for a discussion
Subaim 1
* Radiologists interpreting digital mammography and/or tomosynthesis for at least one year from 2010-2017 at a facility that participates in the BCSC
* Women at least 18 years of age with a first breast cancer diagnosis (DCIS or invasive) from 2005-2017 for whom there was a mammogram performed within the year prior to breast cancer diagnosis at one of the participating BCSC registry facilities
* Women for whom we have pathologically-confirmed breast cancer (DCIS or invasive) with a pathology or biopsy record related to the incident cancer diagnosis in the BCSC data
* MRI and mammography examinations performed for pre-operative work-up from 2005-2017 at one of the participating BCSC registry facilities in women meeting eligibility criteria
Aim 2 Patient Reported Outcomes
* Women at least 18 years of age with a first pathology-confirmed breast cancer diagnosis (DCIS or stage I-III invasive) within 6-18 months
* Known breast density at the time of breast cancer diagnosis
Aim 2 Focus Groups
* Women age ≥18 with a first breast cancer diagnosis (DCIS or stage I-III invasive cancer) within 1-5 years and after completion of active breast cancer treatment who have undergone mammography or MRI pre-operatively.
* Women who are able to speak English and can travel to a nearby location for a discussion
COVID-19 Enhancement Focus Groups
* Women age 18-74 who were due for breast imaging services during the COVID pandemic and have either canceled their appointment, delayed their appointment, or kept their appointment
* Women who are able to speak English and can attend calls virtually through Zoom or over the phone
* In addition, for focus groups with women who have prior breast cancer:
1. First breast cancer diagnosis (DCIS or stage I-III invasive cancer) within 1-3 years prior to March, 2020.
2. Completed active cancer treatment (ongoing endocrine and Herceptin therapy acceptable)
3. No evidence of a second breast cancer event in cancer registry or pathology data before recruitment.
Exclusion Criteria
* Unilateral mammograms and mammograms performed within 9 months of a prior mammogram to avoid classifying diagnostic exams as screening
* Exams without complete cancer capture during the follow-up period
Aim 1 Patient Reported Outcomes
* Exams performed on women with a history of breast cancer, mastectomy, or breast augmentation
* Unilateral mammograms and mammograms performed within 9 months of a prior mammogram to avoid classifying diagnostic exams as screening
* Exams without complete cancer capture during one year following the screening mammogram
Aim 2 Clinical Outcomes
18 Years
89 Years
FEMALE
No
Sponsors
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Patient-Centered Outcomes Research Institute
OTHER
University of California, San Francisco
OTHER
Dartmouth College
OTHER
Kaiser Permanente
OTHER
University of Vermont
OTHER
University of North Carolina
OTHER
University of Illinois at Chicago
OTHER
Wake Forest University Health Sciences
OTHER
Harvard Pilgrim Health Care
OTHER
Albert Einstein College of Medicine
OTHER
Erasmus Medical Center
OTHER
University of California, Davis
OTHER
Responsible Party
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Principal Investigators
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Diana L Miglioretti, PhD
Role: PRINCIPAL_INVESTIGATOR
University of California, Davis
Locations
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Sacramento Area Breast Imaging Registry
Davis, California, United States
San Francisco Mammography Registry
San Francisco, California, United States
Metro Chicago Breast Cancer Registry
Chicago, Illinois, United States
New Hampshire Mammography Network
Lebanon, New Hampshire, United States
Carolina Mammography Registry
Chapel Hill, North Carolina, United States
Vermont Breast Cancer Surveillance System
Burlington, Vermont, United States
Kaiser Permanente Washington Breast Cancer Surveillance Registry
Seattle, Washington, United States
Countries
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References
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Smith RE, Sprague BL, Henderson LM, Kerlikowske K, Miglioretti DL, Wernli KJ, Onega T, diFlorio-Alexander RM, Tosteson ANA. Breast density knowledge and willingness to delay treatment for pre-operative breast cancer imaging among women with a personal history of breast cancer. Breast Cancer Res. 2024 Apr 29;26(1):73. doi: 10.1186/s13058-024-01820-x.
Tosteson ANA, Schifferdecker KE, Smith RE, Wernli KJ, Zhao W, Kaplan CP, Buist DSM, Henderson LM, Sprague BL, Onega T, Budesky J, Jackson-Nefertiti G, Johnson D, Miglioretti DL, Kerlikowske K. Women's Breast Cancer Screening Confidence by Screening Modality and Breast Density: A Breast Cancer Surveillance Consortium Survey Study. J Womens Health (Larchmt). 2022 Nov;31(11):1547-1556. doi: 10.1089/jwh.2021.0649.
Onega T, Zhu W, Kerlikowske K, Miglioretti DL, Lee CI, Henderson LM, Tosteson ANA, Wernli KJ, diFlorio R, Weaver DL, Buist DSM. Preoperative MRI in breast cancer: effect of breast density on biopsy rate and yield. Breast Cancer Res Treat. 2022 Jan;191(1):177-190. doi: 10.1007/s10549-021-06418-x. Epub 2021 Oct 22.
Related Links
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Breast Cancer Surveillance Consortium (BCSC)
Other Identifiers
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PCS-1504-30370
Identifier Type: OTHER
Identifier Source: secondary_id
941466
Identifier Type: -
Identifier Source: org_study_id