Registry for Breast Cancer Patients with Dense Breast Tissue Undergoing MRI
Surveillance MRI Registry for Patients Who Had Breast Cancer With Dense Breast Tissue
This study is creating a registry for women aged 50 and under who have had breast cancer and dense breast tissue to see how well MRI scans work for monitoring their health and to understand their experiences with these scans.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | M.D. Anderson Cancer Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06127797 on ClinicalTrials.gov |
What this trial studies
This observational study aims to create a registry of participants who have a personal history of breast cancer and dense breast tissue, specifically those aged 50 or under. Researchers will analyze data from breast MRI scans to assess the frequency of false positive biopsies and the incidence of interval cancers. The study will also evaluate the positive and negative predictive values of surveillance MRI and explore patient experiences and preferences regarding MRI procedures. Additionally, it will investigate the reasons some women decline MRI for surveillance.
Who should consider this trial
Good fit: Ideal candidates are women aged 50 or younger with a personal history of breast cancer and mammographically dense breasts.
Not a fit: Patients who do not have a history of breast cancer or those over the age of 50 may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of breast cancer surveillance in women with dense breast tissue, potentially leading to better outcomes.
How similar studies have performed: Other studies have explored breast MRI in similar populations, but this specific registry approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Houston, Texas
- MD Anderson Cancer Center — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Huong Le-Petross, MD — M.D. Anderson Cancer Center
- Study coordinator: Huong Le-Petross, MD
- Email: hlepetross@mdanderson.org
- Phone: 713-563-7827
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.