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Non-Contrast Perfusion Using Arterial Spin Labeled MR Imaging for Assessment of Therapy Response in Glioblastoma

NCT03922984 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2024-10-22

No results posted yet for this study

Summary

MRI including ASL will be performed before, during and after the treatment, in a total of 7 MRI sessions until 8 months after the first session. Thereafter, patients will be followed through standard clinical examinations for the next 3 years or until demise, whichever occurs first.

Clinically, GBM patients are imaged every 8-weeks, beginning at 10 weeks after the completion of chemoradiation, since morphological (i.e. size) changes are not anticipated earlier. However, our preliminary experience and others have shown functional changes including perfusion and diffusion as early as 3-weeks after the initiation of the treatment . Thus, our T10, T18, T26 and T34 MRI sessions will be performed along with the clinical imaging sessions, while the T3 and T6 MRI sessions will be performed additionally for this proposal. All MR imaging sessions will be scheduled within ±1 or ±2 weeks of the target time period, as indicated in the table.

MRI including ASL will be performed before, during and after the treatment, in a total of 7 MRI sessions until 8 months after the first session. The research MR imaging may take approximately an additional 15 minutes per each imaging session. However, the T3, and T6 MR imaging sessions will be performed additionally for the purpose of this study, with each taking approximately one hour. Thereafter, patients will be followed through standard clinical examinations for the next 3 years or until demise, whichever occurs first.

Conditions

Interventions

PROCEDURE

MRI with Arterial Spin Labeling (ASL)

Week 0 (Before initiation of chemoradiation): MRI with ASL will be performed along with patient's standard of care imaging session Week 3: contrast-enhanced research MRI with ASL Week 6: contrast-enhanced research MRI with ASL Week 10: MRI with ASL will be performed along with patient's standard of care imaging session Week 18: MRI with ASL will be performed along with patient's standard of care imaging session Week 26: MRI with ASL will be performed along with patient's standard of care imaging session Week 34: MRI with ASL will be performed along with patient's standard of care imaging session

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Ananth Madhuranthakam, PhD · UT Southwestern Medical Center

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-16
Primary Completion
2024-01-22
Completion
2024-01-22

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03922984 on ClinicalTrials.gov