- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02301767
MRI Background Parenchymal Enhancement as a Risk Factor for Breast Cancer: The IMAGINg and Epidemiology (IMAGINE) Study
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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New Jersey
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Basking Ridge, New Jersey, United States
- Memorial Sloan Kettering Cancer Center
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Middletown, New Jersey, United States, 07748
- Memorial Sloan Kettering Monmouth
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New York
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Commack, New York, United States, 11725
- Memorial Sloan Kettering Cancer Center @ Suffolk
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Harrison, New York, United States, 10604
- Memorial Sloan Kettering Westchester
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104-4283
- University of Pennsylvania
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Utah
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Salt Lake City, Utah, United States, 84112
- University of Utah
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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 Criteria:
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Case/control status
Time Frame: 2 years
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2 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Complete questionnaires
Time Frame: 2 years
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2 years
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MRI-BPE measurements
Time Frame: 2 years
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2 years
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MRI-FGT measurements
Time Frame: 2 years
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2 years
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Collaborators and Investigators
Investigators
- Principal Investigator: Jonine Bernstein, PhD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-246
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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