Development and Validation of Advanced MRI Methods for Clinical Applications

NCT03264300 | Unknown DMC FDA Device

• 2 other identifiers: PHXA-16-0235-10-081R01CA213158-01A1
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

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

Keywords

brain tumor, MRI

Outcome Measures

Primary Outcomes (3)

• cerebral blood volume

  In patients with brain tumors we will develop and optimize advanced MRI methods to characterize blood volume.

  Within 60 days of MRI

• the contrast agent extravasation rate constant (Ktrans, 1/min)

  In patients with brain tumors we will develop and optimize advanced MRI methods to characterize Ktrans

  Within 60 days of MRI

• Repeatability coefficient

  will assess the repeatability of MRI

  within 60 days of MRI

Secondary Outcomes (1)

• Intraclass correlation coefficient

  Within 60 days of MRI

Study Arms (2)

Development of advanced MRI methods

ACTIVE COMPARATOR

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.

Other: MRI

Validation of rCBV accuracy

ACTIVE COMPARATOR

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

Other: MRI

Interventions

MRI OTHER

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.

Development of advanced MRI methods

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Joseph's Hospital and Medical Center, Phoenix: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, 85013, United States

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• C C Quarles, PhD

  St. Joseph's Hospital and Medical Center, Phoenix

  PRINCIPAL INVESTIGATOR

• Ashley M Stokes, PhD

  St. Joseph's Hospital and Medical Center, Phoenix

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa Arnold, BS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Operations Manager

Study Record Dates

• First Submitted: July 11, 2017
• First Posted: August 29, 2017
• Study Start: June 26, 2017
• Primary Completion: June 26, 2022
• Study Completion: October 30, 2022
• Last Updated: September 21, 2021

Record last verified: 2021-09

Locations

US (1)