This clinical trial evaluates the usefulness of routine brain magnetic resonance imaging (MRI) in screening for cancer that has spread from the primary site to the brain (brain metastases) in patients with stage IV breast cancer. Breast cancer is one of the most common cancers to metastasize to the brain. Patients with early screening-detected brain metastases are more likely to receive treatments that present a decreased risk of nervous system or decline in thinking ability, making early detection of brain metastases very important. An MRI uses powerful magnets and radio waves to make pictures of body tissues and structures. Brain MRI screening is not currently recommended for cancer patients who don't present with neurocognitive symptoms. Introducing routine brain MRI screening for patients with stage IV breast cancer may improve earlier detection and treatment of brain metastases, when compared to the current screening recommendations.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07357298.
Locations matching your search criteria
United States
Florida
Tampa
Moffitt Cancer CenterStatus: Active
Contact: Kamran Ahmed
Phone: 888-663-3488
PRIMARY OBJECTIVE:
I. To determine the treatment characteristics of brain metastases randomized to brain MRI surveillance or standard of care screening.
SECONDARY OBJECTIVES:
I. To determine the frequency of brain metastasis randomized to brain MRI surveillance or standard of care screening.
II. To determine the incidence of leptomeningeal disease in metastatic breast cancer randomized to brain MRI surveillance or standard of care screening.
III. To determine quality of life (QoL) during brain MRI surveillance and following brain metastasis diagnosis in patients randomized to brain MRI surveillance or standard of care screening.
IV. To determine the number of brain metastases at diagnosis in metastatic breast cancer randomized to brain MRI surveillance or standard of care screening.
V. To determine the size of the largest brain metastasis at diagnosis in metastatic breast cancer randomized to brain MRI surveillance or standard of care screening.
VI. To determine overall survival following brain metastasis diagnosis in metastatic breast cancer randomized to brain MRI surveillance or standard of care screening.
VII. To determine brain metastasis specific survival following brain metastasis diagnosis in metastatic breast cancer randomized to brain MRI surveillance or standard of care screening.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo surveillance brain MRI in week 1 and then every 6 months for 24 months. Patients also undergo collection of blood samples on study.
ARM II: Patients undergo standard of care (SOC) MRI screening at week 1. Patients may undergo additional MRI per SOC if suspicious central nervous system (CNS) symptoms are present. Patients also undergo collection of blood samples on study.
Trial PhaseNo phase specified
Trial Typescreening
Lead OrganizationMoffitt Cancer Center
Principal InvestigatorKamran Ahmed
