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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02301767
Recruitment Status : Active, not recruiting
First Posted : November 26, 2014
Last Update Posted : July 19, 2019
Sponsor:
Collaborators:
University of Pennsylvania
University of Utah
University of Toronto
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease
Breast Cancer

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 have undergone or are about to undergo a bilateral breast MRI with contrast to assess extent of disease. The cancer-free controls will be women at high-risk of breast cancer undergoing a bilateral breast MRI with contrast for screening. The MRI collected for the study may be post-biopsy and post-surgery (unilateral lumpectomy/mastectomy), but prior to bilateral mastectomy, radiation, hormonal, and/or chemotherapy. Study participants also need to have a bilateral mammogram available at the study site within 24 months prior to, or up to 24 months after the study MRI (as long as prior to surgery, radiation, hormonal, and/or chemotherapy), to be included in the secondary aim analysis. The MRI/mammogram selected for this study do not need to be conducted at the recruitment site, the digital images just need to be accessible from the patient medical records at the site. Questionnaire data, optional saliva samples, MRIs, mammograms, and medical records will be collected over a 27 month period from women at three NCI-designated comprehensive cancer centers (MSK, Penn, Utah). Each site has demonstrated experience with recruitment, patient interviews and collection of MRIs and mammograms.

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Study Type : Observational
Actual Enrollment : 2187 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: MRI Background Parenchymal Enhancement as a Risk Factor for Breast Cancer: The IMAGINg and Epidemiology (IMAGINE) Study
Study Start Date : November 2014
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort
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.



Primary Outcome Measures :
  1. Case/control status [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. Complete questionnaires [ Time Frame: 2 years ]
  2. MRI-BPE measurements [ Time Frame: 2 years ]
  3. MRI-FGT measurements [ Time Frame: 2 years ]

Biospecimen Retention:   Samples With DNA
saliva


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years to 69 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).
Criteria

Inclusion Criteria:

  • Eligibility Criteria for Breast Cancer Cases (invasive)

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:

  • For either cases or controls prior to study MRI date:

    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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02301767


Locations
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United States, New Jersey
Memoral Sloan Kettering Cancer Center
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, United States, 07748
United States, New York
Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, United States, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, United States, 10604
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104-4283
United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84112
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
University of Pennsylvania
University of Utah
University of Toronto
Investigators
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Principal Investigator: Jonine Bernstein, PhD Memorial Sloan Kettering Cancer Center

Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT02301767     History of Changes
Other Study ID Numbers: 14-246
First Posted: November 26, 2014    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019

Keywords provided by Memorial Sloan Kettering Cancer Center:
MRI
Risk Factor
background Parenchymal Enhancement
(IMAGINE) Study

Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases