Status:
ACTIVE_NOT_RECRUITING
MRI Background Parenchymal Enhancement as a Risk Factor for Breast Cancer: The IMAGINg and Epidemiology (IMAGINE) Study
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
University of Pennsylvania
University of Utah
Conditions:
Breast Cancer
Eligibility:
FEMALE
21-69 years
Brief Summary
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 c...
Detailed Description
Proposed Study Methods Pertaining to the Population, Eligibility and Recruitment In this multi-center hospital-based case-control study, cases will be women diagnosed with incident breast cancer who h...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 1 2026
Estimated Enrollment :
2187 Patients enrolled
Trial Details
Trial ID
NCT02301767
Start Date
November 1 2014
End Date
November 1 2026
Last Update
December 23 2025
Active Locations (7)
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1
Memorial Sloan Kettering Cancer Center
Basking Ridge, New Jersey, United States
2
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748
3
Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, United States, 11725
4
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604