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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02301767

Collaborator

University of Pennsylvania (Other), University of Utah (Other), University of Toronto (Other)

2,187

Enrollment

Locations

108

Duration (Months)

312.4

Patients Per Site

2.9

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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.

Study Design

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 :

Nov 1, 2014

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Case/control status [2 years]

Secondary Outcome Measures

Complete questionnaires [2 years]
MRI-BPE measurements [2 years]
MRI-FGT measurements [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 69 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memoral 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
5	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
6	University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104-4283
7	University of Utah	Salt Lake City	Utah	United States	84112