Breast NeoplasmsNCT03664778
Abbreviated Breast MRI After Cancer Treatment
An observational study of Breast Neoplasms and Carcinoma, Intraductal, Noninfiltrating, run by University of Pennsylvania at 1 site in United States.
Trial summary
500 patients will be prospectively recruited to undergo a fast breast MRI examination. The women will be recruited for the study will meet the following criteria: 1. status post primary breast cancer treated with breast conservation therapy 3 years prior to recruitment 2. Read more about this study
- Who is it for?
- Ages 18 to 82 years, women only
- Conditions the study is for
- Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating
- How many people
- 184 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Sep 2018to 30 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 82 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women who have had primary breast cancer treated with breast conservation therapy and who fit the inclusion criteria listed below.
Who may be able to join
- Status post primary breast cancer (both invasive and DCIS) treated with breast conservation therapy at least three years prior to recruitment
- Negative DBT examination within six months prior to recruitment
- All breast densities
- Clinically asymptomatic - no palpable masses or focal thickening, etc.
Who cannot join
- Patients who are pregnant or lactating.
- Patients who have not had a mammogram (digital breast tomosynthesis) in the past 6 months.
- Patients who are unwilling or unable to provide written informed consent.
- Patients symptomatic for breast disease (e.g. experiencing discharge, lumps, etc.).
- Recent breast surgery in the past two years including breast enhancements (e.g. implants or injections) benign surgical biopsies.
- Patients who are unable to receive an MRI with Gadolinium contrast.
- Patients who have not had an MRI of the breast within the past year.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cancer Detection Rate of Abbreviated (Fast) Breast MRI (AB-MR) After Negative Digital Breast Tomosynthesis in Women Status Post Conservation Therapy (BCT)
500 patients will be prospectively recruited to undergo a fast breast MRI examination. The women will be recruited for the study will meet the following criteria: 1. status post primary breast cancer treated with breast conservation therapy 3 years prior to recruitment 2. negative DBT examination six months prior to recruitment 3. all breast densities 4. clinically asymptomatic - no palpable masses, focalthickening, or clinically significant discharge We will identify these patients EPIC database utilizing the date of their last mammogram. The patients will be sent a letter explaining the study and the opportunity to enroll in the study. Interested patients may contact our research coordinators by the phone number provided in the letter. The study recruitment information will also be shared with referring physicians. Physicians may also directly refer patients to the study.
Read the detailed description
Women treated for primary breast cancer who undergo breast conservation therapy face an increased risk of developing a second breast cancer in the ipsilateral and the contralateral breast. Although mammographic screening is recommended annually, the sensitivity of mammography is limited in these patients due to the post treatment changes from previous surgery and radiation. We propose supplemental screening with an abbreviated form of breast MRI ("fast MRI") examination in addition to mammographic screening, in order to study whether we can detect subclinical disease that may not be detected on mammography or on physical examination. Several tumor characteristics correlate with overall survival such as the extent of local recurrence and the size of the local recurrence, with larger extent and increased size of local recurrence correlating with adverse survival. In addition, the shorter time interval to the ipsilateral breast cancer recurrence from completion of treatment, is associated with increased risk of developing distant metastasis and breast cancer mortality. We will assess additional cancer detection with fast MRI after negative mammography in the ipsilateral as well as the contralateral breast. The goal of the supplemental screening with fast breast MRI would be to detectsubclinical disease not detected on mammography and thus improve patient outcomes.
- Medical subject headings
- Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating
What is being measured
The primary outcome is the main question the study is designed to answer.
Invasive breast cancer detection
To detect subclinical disease not detected on mammography
Measured: 4 years
Secondary outcomes (5)
DCIS and invasive cancer detection rate
To detect DCIS/Cancer not detected on mammography
Measured: 4 years
Tumor size
Tumor size
Measured: 4 years
Axillary nodal status
Axillary nodal status
Measured: 4 years
Time to recurrence
To determine the time of recurrence
Measured: 4 years
Ipsilateral and contralateral breast cancer detection
Ipsilateral and contralateral breast cancer detection
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2018
- Study start7 Sep 2018
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan Weinstein, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03664778
- Sponsor's protocol ID
- 829400
- Status last verified
- Jan 2026
- First submitted
- 6 Sep 2018
- Last updated
- 13 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Detection Rate of Abbreviated (Fast) Breast MRI (AB-MR) After Negative Digital Breast Tomosynthesis in Women Status Post Conservation Therapy (BCT)
- ClinicalTrials.gov ID
- NCT03664778
- Acronym / sponsor ID
- 829400
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- 7 Sep 2018 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 11 Sep 2018 (actual)
- 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.
500 patients will be prospectively recruited to undergo a fast breast MRI examination. The women will be recruited for the study will meet the following criteria: 1. status post primary breast cancer treated with breast conservation therapy 3 years prior to recruitment 2. negative DBT examination six months prior to recruitment 3. all breast densities 4. clinically asymptomatic - no palpable masses, focalthickening, or clinically significant discharge We will identify these patients EPIC database utilizing the date of their last mammogram. The patients will be sent a letter explaining the study and the opportunity to enroll in the study. Interested patients may contact our research coordinators by the phone number provided in the letter. The study recruitment information will also be shared with referring physicians. Physicians may also directly refer patients to the study.
Detailed description
Women treated for primary breast cancer who undergo breast conservation therapy face an increased risk of developing a second breast cancer in the ipsilateral and the contralateral breast. Although mammographic screening is recommended annually, the sensitivity of mammography is limited in these patients due to the post treatment changes from previous surgery and radiation. We propose supplemental screening with an abbreviated form of breast MRI ("fast MRI") examination in addition to mammographic screening, in order to study whether we can detect subclinical disease that may not be detected on mammography or on physical examination. Several tumor characteristics correlate with overall survival such as the extent of local recurrence and the size of the local recurrence, with larger extent and increased size of local recurrence correlating with adverse survival. In addition, the shorter time interval to the ipsilateral breast cancer recurrence from completion of treatment, is associated with increased risk of developing distant metastasis and breast cancer mortality. We will assess additional cancer detection with fast MRI after negative mammography in the ipsilateral as well as the contralateral breast. The goal of the supplemental screening with fast breast MRI would be to detectsubclinical disease not detected on mammography and thus improve patient outcomes.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 82 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women who have had primary breast cancer treated with breast conservation therapy and who fit the inclusion criteria listed below.
Key inclusion criteria (4 listed)
- Status post primary breast cancer (both invasive and DCIS) treated with breast conservation therapy at least three years prior to recruitment
- Negative DBT examination within six months prior to recruitment
- All breast densities
- Clinically asymptomatic - no palpable masses or focal thickening, etc.
Key exclusion criteria (7 listed)
- Patients who are pregnant or lactating.
- Patients who have not had a mammogram (digital breast tomosynthesis) in the past 6 months.
- Patients who are unwilling or unable to provide written informed consent.
- Patients symptomatic for breast disease (e.g. experiencing discharge, lumps, etc.).
- Recent breast surgery in the past two years including breast enhancements (e.g. implants or injections) benign surgical biopsies.
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
Invasive breast cancer detection
Time frame: 4 years
To detect subclinical disease not detected on mammography
5 secondary outcomes
DCIS and invasive cancer detection rate
Time frame: 4 years
Tumor size
Time frame: 4 years
Axillary nodal status
Time frame: 4 years
Time to recurrence
Time frame: 4 years
Ipsilateral and contralateral breast cancer detection
Time frame: 4 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2026.
- Individual participant dataSharing planned: No
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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.
Susan Weinstein, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms and Carcinoma, Intraductal, Noninfiltrating, run by University of Pennsylvania at 1 site 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 4 inclusion and 7 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: finished, as of the sponsor's last update on 13 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Invasive breast cancer detection (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jan 2026.