Advanced Perfusion MRI of Treatment Response and Progression in Glioblastoma

Sponsor
University of Wisconsin, Madison (Other)
Overall Status
Suspended
CT.gov ID
NCT02769806
Collaborator
National Institute for Biomedical Imaging and Bioengineering (NIBIB) (NIH)
25
1
82.3
0.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
25 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Advanced Perfusion MRI of Treatment Response and Progression in Glioblastoma
Actual Study Start Date :
May 23, 2016
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Apr 1, 2023

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 82 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Wisconsin Carbone Cancer Center Madison Wisconsin United States 53792

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Alexey Samsonov, University of Wisconsin, Madison

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT02769806
Other Study ID Numbers:
  • UW15098
  • 2016-0007
  • A539300
  • SMPH\RADIOLOGY\RADIOLOGY
  • NCI-2019-06444
  • R21EB018483-01A1
First Posted:
May 12, 2016
Last Update Posted:
Feb 3, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 3, 2022