Advanced Perfusion MRI of Treatment Response and Progression in Glioblastoma

The primary aim of this project is to Compare new msCS and standard DSC-PWI methods in GBM patients undergoing post-operative MRI for monitoring of tumor progression.

Study Overview

• Status: Terminated
• Conditions: Glioblastoma; Glioblastoma Multiforme
• Intervention / Treatment: Procedure: MRI

Detailed Description

Investigators will compare the novel to the standard DSC-PWI methods in twenty five GBM patients to determine whether novel method improves image quality in tumor regions. We will also compare accuracy of pseudoprogression (PsP) vs. early progressive disease (ePD) determinations by the two techniques. If successful, the project will culminate in a novel imaging method sequence optimized to monitor progression and guide treatment decisions in post-operative GBM patients.

• Study Type: Observational
• Enrollment (Actual): 16

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • University of Wisconsin Carbone Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 82 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

A total of 25 patients diagnosed with GBM will be enrolled and stratified by the methylation status of their tumor; 17 MGMT-unmethylated and 8 MFMT-methylated will be enrolled.

Description

Inclusion Criteria:

• Histology: Glioblastoma (grade 4 astrocytoma)
• Standard-of-care, post-gd T1w image changes suggestive or consistent with of progression.
• Standard-of-care MRI included conventional DSC-PWI without unexpected technical difficulties.
• Methylation status of tumor available in medical record.
• Able to provide written informed consent.

Exclusion Criteria:

• Contraindications either to 3T MRI (e.g. certain metallic and electronic implants, claustrophobia) or IV gadolinium contrast (allergy, pregnancy, breast-feeding, renal insufficiency). Screening for these contraindications will be based on history only (as it is for all routine outpatient clinical MRI at UWHC).
• Significant physical or mental disease which would preclude successful compliance and participation in the study or, in the opinion of the principal investigator, or co-investigator, constitute a hazard, such that enrollment in the study would not be in the patient's best interest.
• Special subjects such as minors, mentally disabled persons, or prisoners.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
GBM patients undergoing MRI; GBM patients undergoing standard-of-care post-operative combination chemoRT and clinically indicated MRI including standard DSC-PWI for follow-up.	Procedure: MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
A novel high resolution DSC-PWI imaging method	A novel high resolution DSC-PWI method will be compared to the standard DSC-PWI method to determine whether novel method improves image quality in tumor regions.	2 years

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
• Investigators: Principal Investigator: Alexey Samsonov, University of Wisconsin, Madison

Publications and helpful links

Helpful Links

• UW Carbone Cancer Center Home Page

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2016
• Primary Completion (Actual): June 21, 2019
• Study Completion (Actual): June 21, 2019

Study Registration Dates

• First Submitted: May 10, 2016
• First Submitted That Met QC Criteria: May 10, 2016
• First Posted (Estimate): May 12, 2016

Study Record Updates

• Last Update Posted (Estimate): January 16, 2023
• Last Update Submitted That Met QC Criteria: January 12, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Glioblastoma
• Other Study ID Numbers: UW15098; A539300 (Other Identifier: UW Madison); 2016-0007 (Other Identifier: Institutional Review Board); SMPH\RADIOLOGY\RADIOLOGY (Other Identifier: UW Madison); NCI-2019-06444 (Registry Identifier: NCI Trial ID); R21EB018483-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Currently, there is no plan to share data.