Clinical Trial: Ferumoxytol-enhanced Imaging and Mapping in neuroAIDS

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Ferumoxytol-enhanced Imaging and Quantitative Susceptibility Mapping in neuroAIDS

Brief Summary: This project will investigate the ability of a novel MRI contrast agent to identify and quantitate ongoing monocyte/macrophage (M/MΦ)-mediated inflammation in the brains of HIV-infected individuals.

Detailed Summary: HIV-associated neurocognitive disorders (HAND) continue to be prevalent despite effective combination antiretroviral therapy (cART) and have a significant impact on morbidity and quality of life. Monocytes/macrophages (M/MΦ) are believed to play a critical role in the pathogenesis of HAND. Neuroimaging HIV research has not focused on assessing M/MΦ-mediated inflammation in the brain. Currently, no neuroimaging modality exists that can define the extent of active inflammation due to M/MΦ in HAND either as a clinical diagnostic tool or to assist in defining objective improvement in clinical trials addressing HAND. Ferumoxytol is an ultra-small iron oxide MRI contrast agent avidly taken up by circulating M/MΦ. The investigators hypothesize that ferumoxytol-based imaging can identify ongoing inflammation due to perivascular M/MΦ which is believed to represent a key pathologic correlate of HAND.
Sponsor: Beau Nakamoto

Current Primary Outcome: Change in the proportion of abnormal MRIs [ Time Frame: Change from Baseline MRI at 4-6 weeks post-infusion MRI ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Change in quantitative susceptibility mapping (QSM) [ Time Frame: Change from Baseline MRI at 4-6 weeks post-infusion MRI ]

Original Secondary Outcome: Same as current

Information By: University of Hawaii

Dates:
Date Received: February 2, 2016
Date Started: February 2015
Date Completion: April 2017
Last Updated: October 25, 2016
Last Verified: October 2016