Advanced Perfusion MRI of Treatment Response and Progression in Glioblastoma

NCT ID: NCT02769806

Last Updated: 2023-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-23

Study Completion Date

2019-06-21

Brief Summary

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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

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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.

Conditions

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Glioblastoma Glioblastoma Multiforme

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

MRI

Intervention Type PROCEDURE

Interventions

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MRI

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

82 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute for Biomedical Imaging and Bioengineering (NIBIB)

NIH

Sponsor Role collaborator

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alexey Samsonov

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

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University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, United States

Site Status

Countries

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United States

Related Links

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https://cancer.wisc.edu/

UW Carbone Cancer Center Home Page

Other Identifiers

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2016-0007

Identifier Type: OTHER

Identifier Source: secondary_id

A539300

Identifier Type: OTHER

Identifier Source: secondary_id

SMPH\RADIOLOGY\RADIOLOGY

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2019-06444

Identifier Type: REGISTRY

Identifier Source: secondary_id

R21EB018483-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UW15098

Identifier Type: -

Identifier Source: org_study_id

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