Dynamic contrast-enhanced (DCE) magnetic resonance imaging (MRI) is a potentially powerful diagnostic tool for the management of brain cancer and other conditions in which the blood-brain barrier is compromised. This trial studies how well precise DCE MRI works in diagnosing participants with high grade glioma that has come back or melanoma that has spread to the brain. The specially-tailored acquisition and reconstruction (STAR) DCE MRI could provide improved assessment of brain tumor status and response to therapy.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03698162.
PRIMARY OBJECTIVE:
I. To optimize and technically validate specially-tailored acquisition and reconstruction (STAR) DCE-MRI based on the accuracy and reproducibility of whole-brain tracer-kinetic (TK) parameter maps.
SECONDARY OBJECTIVES:
I. To develop a robust clinical implementation of STAR DCE-MRI.
II. To clinically evaluate STAR DCE-MRI in patients with brain tumors.
OUTLINE: Participants are assigned to 1 of 3 cohorts.
COHORT 0: Participants with high-grade glioma undergo STAR-DCE-MRI 3-7 days after their clinically indicated scan.
COHORT I: Participants with recurrent high-grade glioma undergo STAR DCE-MRI every 2 months, and just prior to and 4-6 weeks after starting bevacizumab treatment. If there is concern for tumor progression (i.e. increased contrast enhancement), more frequent MRI scans will be scheduled.
COHORT II: Participants with melanoma brain metastases undergo STAR DCE-MRI at baseline and 4-6 weeks after therapy. Participants may undergo more frequent MRI if there is concern for tumor progression.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationUSC / Norris Comprehensive Cancer Center
Principal InvestigatorKrishna Nayak