Recruiting

MRI Methods

Sponsor:

St. Joseph's Hospital and Medical Center, Phoenix

Code:

NCT03264300

Conditions

Brain Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MRI

MRI

Study Details

Brief 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

Study ID

NCT03264300

Start date

Jun 26, 2017

Status verified date

Sep, 2021

Completion date

Oct 30, 2022

Anticipated

Primary completion date

Jun 26, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Must have either radiological or established histological diagnosis of the following: glioma / central nervous system (CNS) lymphoma / meningioma or brain metastases.
  • Willing and able to provide written informed consent in compliance with the regulatory requirements. If a subject is unable to provide written informed consent, written informed consent may be obtained from the subject's legal representative.
  • In the opinion of the investigator, able to fully participate in the study and sufficiently proficient in English to be capable of reliably completing study assessments.
  • Sexually active women of child-bearing potential (Groups 1 and 2) and men (Group 2 only) must agree to use adequate methods to avoid pregnancy.

Exclusion Criteria:

  • Subjects who have a contraindication for MRI: presence of an incompatible bio-implants (e.g., pacemakers, neurostimulators, electronic infusion pumps, etc.), metal in their bodies (non-MRI compatible cerebral aneurysm clips, shrapnel, metallic fragments in or near the eyes as pertains to metal workers and machinists), or noticeable anxiety and/or claustrophobia and/or severe vertigo when moved into the magnet bore.
  • Subjects who are pregnant or lactating or who suspect they might be pregnant.
  • (Groups 1 and 2, subjects receiving intravenous gadolinium (Gd) contrast material). Subjects with renal insufficiency or known allergy to Gd-based contrast material.
  • (Group 2 only) Subjects with known or suspected iron overload.
  • (Group 2 only) Subjects with known allergic or hypersensitivity reactions to parenteral iron treatment or other intravenous iron products; subjects with significant drug or other allergies or autoimmune diseases may be enrolled at the investigator's discretion.
  • Unwilling or unable to comply with the requirements of this protocol, including the presence of any condition (physical, mental, or social) that is likely to affect the subject's ability to comply with the protocol.
  • Any other reasons that, in the opinion of the Investigator, the candidate is determined to be unsuitable for entry into the study.

Study Design

Enrollment

220 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

active comparator: Development of advanced MRI methods

Subjects with brain tumor. Subjects may be scanned using a single time-point to permit development and optimization of advanced MRI methods. Subjects may be scanned up to two times, with both visits occurring within one month, to permit analysis of test-retest reliability/repeatability.

active comparator: Validation of rCBV accuracy

64 subjects with primary glioma and 96 subjects with recurrent glioma. Subjects will be scanned using a single time-point to validate rCBV accuracy.

Interventions

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.

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.

Primary outcome measure

  • cerebral blood volume [ Time Frame: Within 60 days of MRI ]
  • the contrast agent extravasation rate constant (Ktrans, 1/min) [ Time Frame: Within 60 days of MRI ]
  • Repeatability coefficient [ Time Frame: within 60 days of MRI ]

Central Contacts and Locations

Central contacts

Lisa Arnold, BS

602-406-9593Lisa.Arnold@dignityhealth.org

Locations

St. Joseph's Hospital and Medical Center

Recruiting

Phoenix, Arizona, United States, 85013

Contacts

Lisa Arnold, BS

602-406-9593Lisa.Arnold@dignityhealth.org

Principal Investigator:

C C Quarles, PhD

More Information

Sponsor

St. Joseph's Hospital and Medical Center, Phoenix

Last update posted

Sep 21, 2021

Last verified

Sep, 2021

Keywords

  • brain tumor, MRI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by St. Joseph's Hospital and Medical Center, Phoenix on 2021-09-21.