Advanced Perfusion MRI of Treatment Response and Progression in Glioblastoma

Terminated

• Conditions: Glioblastoma; Glioblastoma Multiforme
• Interventions: Procedure: MRI

• Registration Number: NCT02769806
• Lead Sponsor: University of Wisconsin, Madison

Brief Summary

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.

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 Timeline

• Study First Submitted: 2016-05-10
• Study First Submitted QC: 2016-05-10
• Study First Posted: 2016-05-12
• Study Start: 2016-05-23
• Primary Completion: 2019-06-21
• Study Completion: 2019-06-21
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-12
• Last Update Posted: 2023-01-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GBM patients undergoing MRI	MRI	GBM patients undergoing standard-of-care post-operative combination chemoRT and clinically indicated MRI including standard DSC-PWI for follow-up.

Primary Outcome Measures

Name	Time	Method
A novel high resolution DSC-PWI imaging method	2 years	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.

Trial Locations

Locations (1)

University of Wisconsin Carbone Cancer Center; 🇺🇸 Madison, Wisconsin, United States