MRI Background Parenchymal Enhancement as a Risk Factor for Breast Cancer: The IMAGINg and Epidemiology (IMAGINE) Study
NCT ID: NCT02301767
Last Updated: 2025-12-23
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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ACTIVE_NOT_RECRUITING
2187 participants
OBSERVATIONAL
2014-11-30
2026-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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women that are diagnosed with breast cancer
To complete the study women need to have undergone their scheduled contrast-enhanced MRI, completed the study questionnaire, and provided written consent to release MRIs/mammograms. Although attempts will be made to obtain written consent from all women, the questionnaire data captured from the women who only provide verbal consent may be used in analysis. Optional saliva samples will also be collected for future use.
No interventions assigned to this group
women at high risk of breast cancer
To complete the study women need to have undergone their scheduled contrast-enhanced MRI, completed the study questionnaire, and provided written consent to release MRIs/mammograms. Although attempts will be made to obtain written consent from all women, the questionnaire data captured from the women who only provide verbal consent may be used in analysis. Optional saliva samples will also be collected for future use.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Women with the following characteristics at MRI will be eligible as invasive cases:
1. have a diagnosed invasive unilateral breast cancer after 1/1/2010;
2. have a pre-treatment (prior to bilateral mastectomy, radiation, hormonal, and/or chemotherapy) bilateral breast MRI with contrast available from the study site;
3. be ≥ 21 and \<70 years old at time of diagnosis; and
4. have an intact contralateral breast at the time of study MRI.
Eligibility Criteria for Breast Cancer Cases (non-invasive)
Women with the following characteristics at MRI will be eligible as non-invasive cases:
have a diagnosed unilateral ductal carcinoma in situ (DCIS) preferably after 1/1/2013; 2) have a pre-treatment (prior to bilateral mastectomy, radiation, hormonal, and/or chemotherapy) bilateral breast MRI with contrast available from the study site; 3) be ≥ 21 and \<70 years old at time of diagnosis; and 4) have an intact contralateral breast. The contralateral breast needs to be intact and unaffected by an invasive carcinoma and/or DCIS so the MRI reading can be done on the breast without cancer. Women with a history of previous cancer diagnosis are excluded because treatment they may have received for these cancers might affect the MRI readings.
Eligibility Criteria for Controls Controls will be women determined to be at high risk of developing breast cancer (i.e., lifetime risk ≥20%
Controls must meet the following criteria:
1. have a bilateral breast MRI screening with contrast available from the study site;
2. be ≥ 21 and \<70 years old at time of MRI; and
3. negative breast MRI screen.
Exclusion Criteria
1. unable to speak and read English;
2. history of prophylactic mastectomy;
3. history of pre-pectoral breast implants in either breast (sub-pectoral are acceptable);
4. history of breast reduction surgery;
5. currently taking, or in the previous 3 months: hormonal medication such as Tamoxifen (Nolvadex), Raloxifene (Evista), aromatase inhibitors (Anastrozole/Arimidex, Letrozole/Femara, and/or Exemestane/Aromasin); and/or other postmenopausal hormonal therapy (PHT) medication; and/or hormonal medication for fertility treatment; \[Note: Women are INELIGIBLE if they report taking pills orally, use a patch or ring, even if just intermittently used. Women are ELIGIBLE if they report just taking hormone replacement therapy in the form of a cream, suppository (or intra-vaginal), soy-based, or other natural product.\]
6. currently, or in the preceding 6 months, pregnant or breast feeding; and
7. history of previous cancer including DCIS \[Note: Women are ELIGIBLE if diagnosed with non melanoma skin cancer lobular carcinoma in situ (LCIS) and/or cervical cancer in situ \].
Notes: Women recently diagnosed with DCIS within the study period will be categorized as non-invasive cases (preferable prospective recruitment only). Only one breast may be affected by a recent diagnosis of invasive carcinoma and/or DCIS.
21 Years
69 Years
FEMALE
No
Sponsors
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University of Pennsylvania
OTHER
University of Utah
OTHER
University of Toronto
OTHER
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Jonine Bernstein, PhD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Cancer Center
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States
Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, United States
Memorial Sloan Kettering Westchester
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Utah
Salt Lake City, Utah, United States
Countries
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References
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Watt GP, Thakran S, Sung JS, Jochelson MS, Lobbes MBI, Weinstein SP, Bradbury AR, Buys SS, Morris EA, Apte A, Patel P, Woods M, Liang X, Pike MC, Kontos D, Bernstein JL. Association of Breast Cancer Odds with Background Parenchymal Enhancement Quantified Using a Fully Automated Method at MRI: The IMAGINE Study. Radiology. 2023 Sep;308(3):e230367. doi: 10.1148/radiol.230367.
Provided Documents
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Document Type: Informed Consent Form
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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14-246
Identifier Type: -
Identifier Source: org_study_id