Study of Screening Brain MRIs in Stage IV Breast Cancer
Recruiting · NCT05115474 · Interventional (participants receive a specific treatment) · Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
View the official record on ClinicalTrials.gov →Interventions studied
Magnetic Resonance Imaging
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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
Where it is running
2 locations listed across 1 US state.
- Morton Plant Mease- Baycare - Clearwater, Florida, United States
- Moffitt Cancer Center - Tampa, Florida, United States