Recruiting

Observational StudySurveillance MRI Registry for Patients Who Had Breast Cancer With Dense Breast Tissue

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT06127797

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Questionnaire/Interview

Study Details

Brief 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).

Conditions

Breast Cancer

Study ID

NCT06127797

Start date

Jan 11, 2024

Status verified date

Aug, 2026

Completion date

Aug 31, 2029

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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.
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

Exclusion Criteria:

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
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.

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Questionnaire/Interview

Participation on this study will be over as soon as you complete the questionnaire/interview after your scheduled scans.

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 ]

Central Contacts and Locations

Central contacts

Huong Le-Petross, MD

713-563-7827 hlepetross@mdanderson.org

Locations

MD Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Huong Le-Petross, MD

hlepetross@mdanderson.org

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-08-10.