NCT03698162

Precise DCE-MRI in Diagnosing Participants With Recurrent High Grade Glioma or Melanoma Brain Metastases

Area B: Precise DCE-MRI Assessment of Brain Tumors

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

PRIMARY OBJECTIVES: 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 2 cohorts. 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.

Conditions

• Brain Metastases
• Glioma of Brain
• Brain Tumor
• Metastatic Melanoma

Interventions

Type	Name	Description
OTHER	Dynamic Contrast-Enhanced Magnetic Resonance Imaging	Undergo STAR DCE-MRI
OTHER	Bevacizumab Injection	Bevacizumab will be give to participants who have recurrent high-grade glioma as part of standard of care.

Timeline

• Start date: 2021-04-13
• Primary completion: 2023-11-22
• Completion: 2025-03-01
• First posted: 2018-10-05
• Last updated: 2025-08-05

Locations

1 site across 1 country: United States