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Can your breast MRI reveal hidden cancer risk?

NCT ID NCT02301767

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 02, 2026 · Updated 2 times

Summary

This study looks at how normal breast tissue appears on MRI and mammogram to see if it can help predict breast cancer risk. Researchers are comparing images and health information from over 2,000 women, including those with and without breast cancer. The goal is to better understand what features in breast tissue might signal higher risk, which could lead to improved screening and prevention strategies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help identify women at higher risk for breast cancer based on MRI findings, leading to better screening strategies.
What could go wrong
This is an observational study, not a treatment trial. It may not directly change patient care, and results may take years to influence practice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

2,187 people

The number who actually took part.

Start date

Nov 2014

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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).

Ages

21 to 69 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Memorial Sloan Kettering Cancer Center

    Basking Ridge, New Jersey, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Cancer Center @ Suffolk

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104-4283, United States

  • University of Utah

    Salt Lake City, Utah, 84112, United States

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