Can your breast MRI reveal hidden cancer risk?
NCT ID NCT02301767
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Breast cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
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
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a common steroid shield breast cancer patients from a dangerous drug side effect?
- Tiny magnetic seeds could guide surgeons to the right lymph node
- New PET tracer aims to light up hidden cancer targets
- Gut bacteria supplement tested against chemo hair loss
- Can a mindfulness program boost Self-Compassion in breast cancer survivors?
- Can a Decades-Old Anti-Inflammatory drug quiet the joint pain that drives women off breast cancer therapy?