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

NCT02301767 | Active Not Recruiting

• 1 other identifier: 14-246
• Study Type: observational
• Target: 2,187
• Locations: 1 country
• Sites: 7

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 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.

Conditions

Breast Cancer

Keywords

MRI; Risk Factor; background Parenchymal Enhancement; (IMAGINE) Study

Outcome Measures

Primary Outcomes (1)

• Case/control status

  2 years

Secondary Outcomes (3)

• Complete questionnaires

  2 years

• MRI-BPE measurements

  2 years

• MRI-FGT measurements

  2 years

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 21 Years - 69 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The three data cancer centers (MSK, Penn, Utah) will recruit 1,110 cases (women diagnosed with breast cancer) and 1,110 matched controls (high risk women).

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.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• University of Pennsylvania: collaborator
• University of Utah: collaborator
• University of Toronto: collaborator

Study Sites (7)

Memorial Sloan Kettering Cancer Center

Basking Ridge, New Jersey, United States

Location

Memorial Sloan Kettering Monmouth

Middletown, New Jersey, 07748, United States

Location

Memorial Sloan Kettering Cancer Center @ Suffolk

Commack, New York, 11725, United States

Location

Memorial Sloan Kettering Westchester

Harrison, New York, 10604, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

Location

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Related Publications (1)

• 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.

  PMID: 37750771 DERIVED

Related Links

• Memorial Sloan Kettering Cancer Center

Biospecimen

Retention: SAMPLES WITH DNA

saliva

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jonine Bernstein, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2014
• First Posted: November 26, 2014
• Study Start: November 1, 2014
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 23, 2025

Record last verified: 2025-12

Locations

US (7)