Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Central Nervous System Neoplasm
  • Cranial Nerve Disorder
  • Metastatic Malignant Neoplasm in the Brain
Type
Interventional
Phase
Phase 2
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Primary Purpose: Diagnostic

Participation Requirements

Age
Between 10 years and 125 years
Gender
Both males and females

Description

PRIMARY OBJECTIVES: I. To test if prior gadolinium administration affects vascular imaging using ferumoxytol. II. To test signal changes of T2*w multi-echo fast field echo (mFFE) scans before and after contrast agent injection. SECONDARY OBJECTIVES: I. To test if ferumoxytol affects gadolinium enhan...

PRIMARY OBJECTIVES: I. To test if prior gadolinium administration affects vascular imaging using ferumoxytol. II. To test signal changes of T2*w multi-echo fast field echo (mFFE) scans before and after contrast agent injection. SECONDARY OBJECTIVES: I. To test if ferumoxytol affects gadolinium enhanced MRI. II. To test if steady state cerebral blood volume (CBV) maps are different at various magnetic field strengths. EXPLORATORY OBJECTIVES: I. To explore late ferumoxytol enhancement (optional MRI) hours to days after ferumoxytol administration in various pathologies. II. To evaluate the effects of ferumoxytol on malignant and non-malignant lesions in head & neck, and liver lesions OUTLINE: Patients are randomized into 1 of 2 groups. GROUP I: Patients receive gadolinium intravenously (IV) and then ferumoxytol IV and undergo MRI over 60 minutes on day 1. GROUP II: Patients receive ferumoxytol IV and then gadolinium IV and undergo MRI over 60 minutes on day 1. After completion of study, patients are followed up at 2 and 6 weeks.

Tracking Information

NCT #
NCT03270059
Collaborators
  • Celgene Corporation
  • Oregon Health and Science University
Investigators
Principal Investigator: Prakash Ambady OHSU Knight Cancer Institute