Breast CancerNCT06127797
Surveillance MRI Registry for Patients Who Had Breast Cancer With Dense Breast Tissue
An observational study of Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To create a registry (database) of participants who come in for breast MRI scans. Researchers want to use this information to study if participants with dense breast tissue (tissue that is more difficult to see on mammogram). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Questionnaire/Interview
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2024to 31 Aug 2029
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Estimate sample size of 1000 patients, with accrual rate of 250 patients per year
Who may be able to join
- Participants 50 years of age or younger who has personal history of breast cancer and mammographically dense breast, per ACR Category C and D.
- Participants must be 18 years of age or older.
- Participants are being seen at MD Anderson for annual surveillance and scheduled for routine screening mammogram and/or DBT, with negative or benign findings.
- Participants must not be pregnant or breast-feeding. If a Participant is of childbearing potential and is uncertain if the Participant could be pregnant or may be pregnant or as per local site standard of practice in women undergoing mammogram/DBT and MRI must have a blood test or urine study within 2 weeks prior to randomization to rule out pregnancy. A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
- The Participants breast density must be known based on prior mammogram or agree to have mammogram or DBT prior to enrollment in order to determine breast density. Participants must have mammographically dense breasts based on American College of Radiology [ACR] Breast Imaging [BI]- Reporting and Data System Atlas (RADS) lexicon categories c or d (heterogeneous or extreme fibroglandular tissue) on their most-recent prior screening mammogram.
- Participants must be asymptomatic for breast disease and undergoing routine screening.
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- Participants must not have untreated breast cancer (DCIS or invasive cancer) or currently undergoing treatment for breast cancer or planning surgery for a high risk lesion (atypical ductal breast hyperplasia [ADH], atypical lobular breast hyperplasia [ALH], lobular breast carcinoma in situ [LCIS], papilloma, radial scar) at the time of enrollment.
- Participants on Tamoxifen can be enrolled in registry trial.
- BRCA, other genetic mutation carriers or relatives of mutation carriers, and participants at high-risk for breast cancer, as defined by the American Cancer Society (ACS) breast MR screening recommendations (lifetime risk of >= 20-25%), can participate. These participants may be analyzed as subsets.
- Participants must be able to undergo breast MRI with contrast enhancement; Participants unable to undergo breast MRI with contrast enhancement for any reason are ineligible.
- No history of untreatable claustrophobia
- No presence of non-MRI compatible metallic objects or metallic objects that, in the opinion of the radiologist, would make MRI a contraindication
- No history of sickle cell disease
- No contraindication to intravenous contrast administration
- No known allergy-like reaction to gadolinium or moderate or severe allergic reactions to one or more allergens as defined by the American College of Radiology (ACR); participants may be eligible if willing to undergo pre-treatment as defined by the institution's policy and/or ACR guidance
- No known or suspected renal impairment; requirements for glomerular filtration rate (GFR) prior to MRI as determined by local site standard practice
- Weight less than or equal to the MRI table limit
- Ability to understand and willingness to sign a written informed consent document
Who cannot join
- metastatic breast cancer
- medically unstable
- known contraindications to MRI
- allergic reactions to paramagnetic contrast agent or severe allergic diathesis
- on renal dialysis or renal dysfunction
- undergone chemotherapy or hormonal therapy for cancer in previous 6 months
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- breast surgery or radiotherapy for cancer to the ipsilateral breast within the past 6 months
- had a history of serious breast trauma within the past 3 months
- pregnant or breastfeeding
- have a disability preventing MRI in a prone position
- some MR conditional implants such as neurostimulators or cardiac monitors, per institutional procedures and policy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Huong Le-Petross, MD, hlepetross@mdanderson.org
About this study
To create a registry (database) of participants who come in for breast MRI scans. Researchers want to use this information to study if participants with dense breast tissue (tissue that is more difficult to see on mammogram).
Read the detailed description
Primary Objectives
- To determine the number of false positive biopsies obtained from surveillance MRI in participant with personal history of breast cancer, age 50 or under, and mammographically dense breasts.
Secondary Objectives
- To determine the incidence of interval cancer.
II. To compare participants with personal history of breast cancer, age 50 and under, who did not receive surveillance MRI.
III. To determine positive predictive value (PPV) and negative predictive value (NPV) of surveillance breast MRI in this population.
IV. To compare the tumor biology of breast cancer detected on breast MRI.
- To determine the participants experience with MRI i.e. willingness to return for testing with breast MRI.
VI. To evaluate the reasons women refuse breast MRI for the surveillance of recurrent disease or secondary breast cancer.
VII. To determine the patients' interest in having procedural hypnosis to improve patient reported acceptance of breast MRI among participants.
- Conditions
- Breast Cancer
- Being tested
- Questionnaire/Interview
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire/InterviewBehavioural
Participation on this study will be over as soon as you complete the questionnaire/interview after your scheduled scans.
| Study group | Role | What they receive |
|---|---|---|
| Questionnaire/Interview | Participants will take part in this study, before and after your routine breast MRI scan, participants will be asked to answer a series of questions about your experience with this MRI. It may take 10 to 20 minutes to answer. Participants may answer these questions in 1 of 3 ways:
* In-person in the clinic with the study team (either through speaking or writing down your answers on a paper or electronic questionnaire form);
* by phone at a later time; or
* by paper or email at a later time. Receives: Behavioral: Questionnaire/Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: through study completion; an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2023
- Study start11 Jan 2024
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huong Le-Petross, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06127797
- Sponsor's protocol ID
- 2023-0618
- Other IDs
- NCI-2023-08950
- Status last verified
- Aug 2026
- First submitted
- 7 Nov 2023
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surveillance MRI Registry for Patients Who Had Breast Cancer With Dense Breast Tissue
- ClinicalTrials.gov ID
- NCT06127797
- Acronym / sponsor ID
- 2023-0618
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 11 Jan 2024 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2029 (estimated)
- First posted
- 13 Nov 2023 (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.
To create a registry (database) of participants who come in for breast MRI scans. Researchers want to use this information to study if participants with dense breast tissue (tissue that is more difficult to see on mammogram).
Detailed description
Primary Objectives
- To determine the number of false positive biopsies obtained from surveillance MRI in participant with personal history of breast cancer, age 50 or under, and mammographically dense breasts.
Secondary Objectives
- To determine the incidence of interval cancer.
II. To compare participants with personal history of breast cancer, age 50 and under, who did not receive surveillance MRI.
III. To determine positive predictive value (PPV) and negative predictive value (NPV) of surveillance breast MRI in this population.
IV. To compare the tumor biology of breast cancer detected on breast MRI.
- To determine the participants experience with MRI i.e. willingness to return for testing with breast MRI.
VI. To evaluate the reasons women refuse breast MRI for the surveillance of recurrent disease or secondary breast cancer.
VII. To determine the patients' interest in having procedural hypnosis to improve patient reported acceptance of breast MRI among participants.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Questionnaire/Interview | – | Behavioral: Questionnaire/InterviewParticipants will take part in this study, before and after your routine breast MRI scan, participants will be asked to answer a series of questions about your experience with this MRI. It may take 10 to 20 minutes to answer. Participants may answer these questions in 1 of 3 ways: * In-person in the clinic with the study team (either through speaking or writing down your answers on a paper or electronic questionnaire form); * by phone at a later time; or * by paper or email at a later time. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Estimate sample size of 1000 patients, with accrual rate of 250 patients per year
Key inclusion criteria (18 listed)
- Participants 50 years of age or younger who has personal history of breast cancer and mammographically dense breast, per ACR Category C and D.
- Participants must be 18 years of age or older.
- Participants are being seen at MD Anderson for annual surveillance and scheduled for routine screening mammogram and/or DBT, with negative or benign findings.
- Participants must not be pregnant or breast-feeding. If a Participant is of childbearing potential and is uncertain if the Participant could be pregnant or may be pregnant or as per local site standard of practice in women undergoing mammogram/DBT and MRI must have a blood test or urine study within 2 weeks prior to randomization to rule out pregnancy. A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
- The Participants breast density must be known based on prior mammogram or agree to have mammogram or DBT prior to enrollment in order to determine breast density. Participants must have mammographically dense breasts based on American College of Radiology [ACR] Breast Imaging [BI]- Reporting and Data System Atlas (RADS) lexicon categories c or d (heterogeneous or extreme fibroglandular tissue) on their most-recent prior screening mammogram.
Key exclusion criteria (11 listed)
- metastatic breast cancer
- medically unstable
- known contraindications to MRI
- allergic reactions to paramagnetic contrast agent or severe allergic diathesis
- on renal dialysis or renal dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire/InterviewParticipation on this study will be over as soon as you complete the questionnaire/interview after your scheduled scans. | Behavioural | Questionnaire/Interview |
Primary outcome
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time frame: through study completion; an average of 1 year
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 10 Aug 2026.
- MD Anderson 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.
Huong Le-Petross, MD principal investigator
M.D. Anderson Cancer Center
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 Cancer, run by M.D. Anderson Cancer Center 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 18 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 10 Aug 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?
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?
Contact Huong Le-Petross, MD (713-563-7827, hlepetross@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 (time frame: through study completion; an average of 1 year). 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 10 Aug 2026.