Advanced MR Imaging as Predictor of Treatment Response in Newly Diagnosed Glioblastomas

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

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-12

Study Completion Date

2025-12-31

Brief Summary

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This clinical trial studies advanced MR imaging techniques in measuring early response of standard treatment may become predictors of long-term treatment response in patients with newly diagnosed glioblastomas.

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Detailed Description

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The standard care of patients with glioblastoma is concomitant chemoradiation and adjuvant temozolomide. Allowing for assessment of tumor therapy prior to treatment completion is important to select patients most likely to benefit from alternative treatment option. Multimodal advanced MR imaging- contrast-enhanced T1 weighted imaging, diffusion-weighted imaging, chemical exchange saturation transfer imaging, and perfusion imaging on 3T enables quantitative assessment of treatment response. Quantifying changes in advanced MR imaging techniques would allow predict outcome for early and long-term treatment response and survival in glioblastomas.

Conditions

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Adult Glioblastoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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MR imaging and standard treatment

Patients with glioblastoma undergo 3-Tesla magnetic resonance imaging to measure tumor protein content (using CEST-MRI), cellularity (using DW-MRI), and perfusion (using DCE-MRI and DSC-MRI with IV administration of gadolinium-containing contrast agent) at pre-CCRT; 4 weeks after completion of the CCRT; and every 2 or 3 months during the adjuvant temozolomide therapy.

Group Type OTHER

3 Tesla magnetic resonance imaging

Intervention Type DEVICE

High resolution structural imaging (contrast-enhanced T1-weighted image, T2-weighted image, Fluid-attenuated inversion recovery)

Chemical exchange saturation transfer MRI

Intervention Type DEVICE

Amide proton transfer-weighted image

Diffusion weighted MRI

Intervention Type DEVICE

diffusion-weighted image with b value 0, 1000, and 3000

Dynamic susceptibility contrast MRI

Intervention Type DEVICE

dual echo EPI sequence

Interventions

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3 Tesla magnetic resonance imaging

High resolution structural imaging (contrast-enhanced T1-weighted image, T2-weighted image, Fluid-attenuated inversion recovery)

Intervention Type DEVICE

Chemical exchange saturation transfer MRI

Amide proton transfer-weighted image

Intervention Type DEVICE

Diffusion weighted MRI

diffusion-weighted image with b value 0, 1000, and 3000

Intervention Type DEVICE

Dynamic susceptibility contrast MRI

dual echo EPI sequence

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patients must have radiologically and histologically confirmed diagnosis of newly diagnosed glioblastoma
* Patients must have measurable disease, defined as evident tumors with gadolinium enhancement on MRI that is measurable in at least one diameter
* Life expectancy of greater than 3 months
* Patients scheduled for standard therapy (6 weeks radiation treatment (RT) \~ 60 Gy, plus temozolomide 75 mg/m\^2 during 6 week RT, and followed routine monthly temozolomide therapy)
* Ability to understand and the willingness to sign a written informed consent document; all patients, or their legal guardians, must sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines

Exclusion Criteria

* Patients who underwent complete resection
* Patients with no evidence of measurable disease after surgery
* Patients who have had chemotherapy or radiotherapy
* Patients who have any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, electronic infusion pumps, etc), because such devices may be displaced or malfunction
* Patients who are pregnant or breast feeding; urine pregnancy test will be performed on women of child bearing potential
* For patients who have undergone surgical resection prior to joining the study, in whom baseline magnetic resonance (MR) images exhibit enough signal degradation (due to susceptibility artifact in the region of the surgical bed) such that the data are uninterpretable will be excluded

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No