NCT04941430

7T MRI Scan for the Early Detection of Melanoma Brain Metastases

Pilot Study of 7T MRI for Early Diagnosis of Melanoma Brain Metastases

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial studies the use of 7-Tesla (7T) magnetic resonance imaging (MRI) in detecting melanoma that has spread to the brain (melanoma brain metastases). The standard MRI brain imaging is done on 3T or similar MRI machine, but the 7T MRI machine has a larger magnet which has been shown to have superior resolution of the brain and of non-cancerous brain lesions. Diagnostic procedures such as 7T MRI may help find and diagnose melanoma brain metastases earlier than standard 3T MRI.

Detailed description

PRIMARY OBJECTIVE: I. Assess the potential superiority of contrast-enhanced (CE) 7T MRI by comparing to standard of care CE 3T MRI in detecting occult brain metastases lesion at time of diagnosis of new brain metastases. SECONDARY OBJECTIVE: I. Describe the imaging characteristics of melanoma brain metastases on 7T MRI of the brain. EXPLORATORY OBJECTIVE: I. Evaluate incidence of diagnosis of leptomeningeal disease on CE 7T MRI brain. OUTLINE: Within 2 weeks of initial standard of care 3T MRI, patients undergo 7T MRI scan with and without contrast over 1-2 hours.

Conditions

• Clinical Stage IV Cutaneous Melanoma AJCC v8
• Metastatic Malignant Neoplasm in the Brain
• Metastatic Melanoma
• Pathologic Stage IV Cutaneous Melanoma AJCC v8

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Magnetic Resonance Imaging using 7 Tesla MRI	Undergo 7T MRI

Timeline

• Start date: 2021-06-25
• Primary completion: 2025-01-10
• Completion: 2025-01-10
• First posted: 2021-06-28
• Last updated: 2025-08-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study