Breast CancerNCT02301767
MRI Background Parenchymal Enhancement as a Risk Factor for Breast Cancer: The IMAGINg and Epidemiology (IMAGINE) Study
An observational study of Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 69 years, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 2,187 participants
- Where
- 7 sitesUnited States
- Study dates
- Nov 2014to Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 69 years
- Women only
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.]
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- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Memorial Sloan Kettering Cancer Center
Basking Ridge, New Jersey
Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, 11725
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4283
University of Utah
Salt Lake City, Utah, 84112
About this study
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.
Read the 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.
- Conditions
- Breast Cancer
- Keywords
- MRI, Risk Factor, background Parenchymal Enhancement, (IMAGINE) Study
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Case/control status
Measured: 2 years
Secondary outcomes (3)
Complete questionnaires
Measured: 2 years
MRI-BPE measurements
Measured: 2 years
MRI-FGT measurements
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2014 (estimated)
- Study startNov 2014
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2,187 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania, University of Utah, University of Toronto
- Responsible party
- Sponsor
- Investigators
- Jonine Bernstein, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02301767
- Sponsor's protocol ID
- 14-246
- Status last verified
- Aug 2026
- First submitted
- 19 Nov 2014
- Last updated
- 1 Sep 2026
- Results posted
- No
Publications
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.
PubMed 37750771
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI Background Parenchymal Enhancement as a Risk Factor for Breast Cancer: The IMAGINg and Epidemiology (IMAGINE) Study
- ClinicalTrials.gov ID
- NCT02301767
- Acronym / sponsor ID
- 14-246
- Conditions
- Breast Cancer
- Keywords
- MRI, Risk Factor, background Parenchymal Enhancement, (IMAGINE) Study
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,187 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- University of Pennsylvania, University of Utah, University of Toronto
- Study start
- Nov 2014
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 26 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 21 to 69 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (14 listed)
- Eligibility Criteria for Breast Cancer Cases (invasive)
- 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.
Key exclusion criteria (9 listed)
- For either cases or controls prior to study MRI date:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Case/control status
Time frame: 2 years
3 secondary outcomes
Complete questionnaires
Time frame: 2 years
MRI-BPE measurements
Time frame: 2 years
MRI-FGT measurements
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2026.
- Derived from this study: PubMed 37750771Watt 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.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonine Bernstein, PhD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Case/control status (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02301767, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2026.