Advanced Perfusion MRI of Treatment Response and Progression in Glioblastoma

NCT02769806 | Terminated DMC

• 6 other identifiers: UW150982016-0007A539300SMPH\RADIOLOGY\RADIOLOGYNCI-2019-06444R21EB018483-01A1
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Glioblastoma; Glioblastoma Multiforme

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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

Interventions

MRI PROCEDURE

GBM patients undergoing MRI

Eligibility Criteria

• Age: 18 Years - 82 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institute for Biomedical Imaging and Bioengineering (NIBIB): collaborator

Study Sites (1)

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53792, United States

Location

Related Links

• UW Carbone Cancer Center Home Page

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Alexey Samsonov

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2016
• First Posted: May 12, 2016
• Study Start: May 23, 2016
• Primary Completion: June 21, 2019
• Study Completion: June 21, 2019
• Last Updated: January 17, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)