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NCT02769806 Clinical Trial

Advanced Perfusion MRI of Treatment Response and Progression in Glioblastoma

Glioblastoma Clinical Trial

Official title:
Advanced Perfusion MRI of Treatment Response and Progression in Glioblastoma

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02769806
Other study ID # UW15098
Secondary ID 2016-0007A539300
Status Terminated
Phase
First received
Last updated
Start date May 23, 2016
Est. completion date June 21, 2019

Study information
Verified date January 2023
Source University of Wisconsin, Madison
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 16
Est. completion date June 21, 2019
Est. primary completion date June 21, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 82 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• MRI

Locations
Country Name City State
United States University of Wisconsin Carbone Cancer Center Madison Wisconsin

Sponsors (2)
Lead Sponsor Collaborator
University of Wisconsin, Madison National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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