MRI Background Parenchymal Enhancement as a Risk Factor for Breast Cancer: The IMAGINg and Epidemiology (IMAGINE) Study

Running, not enrolling

Conditions studied: Breast Cancer

In brief

The purpose of the study is to view what normal breast tissue looks like on an MRI and mammogram to help determine how it may affect the risk of developing breast cancer. The investigators will also compare the information collected from the questionnaire and medical records to help better understand how this may affect the risk of developing breast cancer. If a saliva or tissue sample is collected for future use, this information will enable us to study genetic risk factors as well.

Key facts

Study ID

NCT02301767

Run by

Memorial Sloan Kettering Cancer Center

People needed

2187

Starts

2014-11-01

Expected to finish

2026-11-01

Last updated by the study team

2025-12-23

Who can join

Age: 21 and older, up to 69. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Eligibility Criteria for Breast Cancer Cases (invasive)
• Women with the following characteristics at MRI will be eligible as invasive cases:
• have a diagnosed invasive unilateral breast cancer after 1/1/2010;
• have a pre-treatment (prior to bilateral mastectomy, radiation, hormonal, and/or chemotherapy) bilateral breast MRI with contrast available from the study site;
• be ≥ 21 and <70 years old at time of diagnosis; and
• 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:
• have a bilateral breast MRI screening with contrast available from the study site;
• be ≥ 21 and <70 years old at time of MRI; and
• negative breast MRI screen.

You may not qualify if…

• For either cases or controls prior to study MRI date:
• unable to speak and read English;
• history of prophylactic mastectomy;
• history of pre-pectoral breast implants in either breast (sub-pectoral are acceptable);
• history of breast reduction surgery;
• 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.]
• currently, or in the preceding 6 months, pregnant or breast feeding; and
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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