Development and Validation of Advanced MRI Methods for Clinical Applications

Summary

A critical aspect of brain tumor patient management is the radiographic assessment of tumor status, which is used for diagnosis, localization, surgical planning and surveillance. The primary goal is to develop and apply advanced, quantitative magnetic resonance imaging (MRI) techniques that can supplement existing high-resolution anatomic imaging to aid clinical decision-making for patients diagnosed with brain tumors. The studies proposed herein involve the development of advanced imaging methods that are intrinsically sensitive to the biophysical characteristics associated with tumor pathogenesis, as they are more likely to improve tumor characterization and localization and may offer early and more specific indicators of treatment response. These advanced methods include diffusion-weighted imaging (DWI), chemical exchange saturation transfer (CEST), and dynamic susceptibility contrast (DSC) perfusion MRI. A secondary objective of this study is to validate cerebral blood volume (CBV) metrics acquired using a DSC acquisition and post-processing methods by comparison with an intravascular reference standard contrast agent. Validated perfusion imaging techniques will improve the reliability and relevancy of derived CBV metrics across a range of clinical applications, including tumor localization, treatment guidance, therapy response assessment, surgical and biopsy guidance, and multi-site clinical trials of conventional and targeted brain tumor therapies.

Conditions

• Brain Tumor

Interventions

OTHER

MRI

MRI scans to include: scout images, transmitter tuning, shimming, slice prescription - 5 min; conventional structural MRI; T1-weighted anatomic MRI scan - 7 min; and, T2-weighted anatomic MRI scan - 5 min. Advanced MRI to include: Diffusion Weighted MRI (DW-MRI) - 7 min; Chemical Exchange Saturation Transfer (CEST) - 9 min; Dynamic Susceptibility Contrast / Dynamic Contrast Enhanced MRI - 8 min; and, other advanced imaging, as needed, to be determined. Post-contrast conventional MRI to include T1-weighted anatomic MRI scan - 7 min. Repeat within 1 month.

OTHER

MRI

MRI scans to include: scout images, transmitter tuning, shimming, slice prescription - 5 min. Conventional structural MRI to include: T1-weighted anatomic MRI scan - 7 min; and, T2-weighted anatomic MRI scan - 5 min. Serial DSC-MRI: staged injections of Gd-based contrast and Ferumoxytol - 20 min. Post-contrast conventional MRI: T1-weighted anatomic MRI scan - 7 min.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• St. Joseph's Hospital and Medical Center, Phoenix

  lead OTHER

Principal Investigators

• C C Quarles, PhD · St. Joseph's Hospital and Medical Center, Phoenix

• Ashley M Stokes, PhD · St. Joseph's Hospital and Medical Center, Phoenix

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-06-26

Primary Completion

2022-06-26

Completion

2022-10-30

FDA Device

Yes

Countries

• United States

Study Locations