RecruitingPhase not listed

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "To create a registry (database) of participants who come in for breast MRI scans."
  • "To determine positive predictive value (PPV) and negative predictive value (NPV) of surveillance breast MRI in this population."
  • "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."
  • "To evaluate the reasons women refuse breast MRI for the surveillance of recurrent disease or secondary breast cancer."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility criteria

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 sites (1)

TX