RecruitingNCT05115474
Study of Screening Brain MRIs in Stage IV Breast Cancer
Phase II Study of Screening Brain MRIs in Stage IV Breast Cancer
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Enrollment
170 participants
Start Date
Dec 21, 2021
Study Type
OBSERVATIONAL
Summary
The study is a single arm, nonrandomized phase II prospective study, with the goal of investigating the role of screening brain MRIs in neurologically asymptomatic patients with metastatic breast cancer.
Eligibility
Min Age: 18 Years
Inclusion Criteria8
- Histologic diagnosis of breast cancer with documentation of ER/PR/HER2 status
- Radiographic evidence of stage IV extracranial diease having progressed past first line therapy in HR+/HER2- patients
- Radiographic evidence of stage IV extracranial disease in TN and HER2+ patients
- Age ≥ 18
- Life expectancy ≥ 6 months
- Eastern Cooperative Oncology Group performance status 0 to 2
- Patients must be able to understand and the willingness to sign an informed consent for study procedures
- Stated willingness to comply with all study procedures and availability for the duration of the study
Exclusion Criteria6
- Prior diagnosis or treatment of brain metastases or leptomeningeal disease
- Patients with prior history of non-breast cancer malignancies should have no evidence of disease ≥ 2 years
- Neurologic symptoms warranting standard screening brain MRI in the judgement of the treating physician at time of enrollment
- Indications warranting brain MRI for other neurologic conditions at time of study entry
- Contraindication towards MRI imaging with contrast
- Chronic kidney disease stage IV or V or end stage renal disease
Interventions
DIAGNOSTIC_TESTMagnetic Resonance Imaging
Participants will undergo MRI imaging with and without contrast.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05115474