Surveillance MRI Registry for Patients Who Had Breast Cancer With Dense Breast Tissue

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).

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Questionnaire/Interview

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

I. 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.

V. 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 Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Huong Le-Petross, MD; Phone Number: 713-563-7827; Email: hlepetross@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • Md Anderson Cancer Center
      • Contact: Huong Le-Petross, MD; Email: hlepetross@mdanderson.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Estimate sample size of 1000 patients, with accrual rate of 250 patients per year

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0	through study completion; an average of 1 year

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Huong Le-Petross, MD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2024
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2029

Study Registration Dates

• First Submitted: November 7, 2023
• First Submitted That Met QC Criteria: November 7, 2023
• First Posted (Actual): November 13, 2023

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Interviews as Topic; Surveys and Questionnaires
• Other Study ID Numbers: 2023-0618; NCI-2023-08950 (Other Identifier: NCI-CTRP Clinical Trials Registry)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No