Brief Summary

This pilot clinical trial studies advanced magnetic resonance imaging (MRI) techniques in measuring treatment response in patients with high-grade glioma. New diagnostic procedures, such as advanced MRI techniques at 3 Tesla, may be more effective than standard MRI in measuring treatment response in patients receiving treatment for high-grade gliomas.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for early_phase_1

Timeline

Completed

Started May 2012

Longer than P75 for early_phase_1

Geographic Reach

1 country

1 active site

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

3.7 years study duration

Study Start

First participant enrolled

May 1, 2012

Completed

1.5 years until next milestone

First Submitted

Initial submission to the registry

November 15, 2013

Completed

12 days until next milestone

First Posted

Study publicly available on registry

November 27, 2013

Completed

2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 23, 2015

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed

Last Updated

April 17, 2017

Status Verified

April 1, 2017

Enrollment Period

3.6 years

First QC Date

November 15, 2013

Last Update Submit

April 13, 2017

Conditions

Adult Anaplastic Astrocytoma Adult Anaplastic Ependymoma Adult Anaplastic Oligodendroglioma Adult Giant Cell Glioblastoma Adult Glioblastoma Adult Gliosarcoma Recurrent Adult Brain Tumor

Outcome Measures

Primary Outcomes (1)

Best Response
Number of patients in each response category, per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1, summarized as follows for target lesion criteria: complete response (CR),disappearance of target lesions; partial response (PR), \>=30% decrease in sum of longest diameter (LD) of target lesions; progressive disease (PD), \>=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or SD. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR\>PR\>SD\>PD.
On-treatment date to date of disease progression (up to 12 weeks)

Secondary Outcomes (1)

Progression Free Survival (PFS)
On-study date to lesser of date of progression or date of death from any cause (assessed at 6 months)

Other Outcomes (6)

Changes in quantitative MRI-based biomarkers sensitive to tumor protein content
Baseline to within 4 weeks after on-treatment date
Changes in quantitative MRI-based biomarkers sensitive to tumor cellularity and vascularity
Baseline to within 4 weeks after on-treatment date
Changes in quantitative MRI-based biomarkers sensitive to tumor perfusion and hemodynamics
Baseline to within 4 weeks after on-treatment date
+3 more other outcomes

Study Arms (1)

3-Tesla magnetic resonance imaging

EXPERIMENTAL

Patients undergo 3-Tesla magnetic resonance imaging to measure tumor protein content (using CEST-MRI), cellularity (using DW-MRI), and blood flow (using DCE-MRI and DSC-MRI with IV administration of gadolinium-containing contrast agent) no more than 2 weeks before, and 2 and 4 weeks after, the initiation of treatment.

Device: 3-Tesla magnetic resonance imagingDevice: CEST-MRIDevice: DW-MRIDevice: DCE-MRIDevice: DSC-MRIDrug: IV administration of gadolinium-containing contrast agent

Interventions

3-Tesla magnetic resonance imagingDEVICE

3-Tesla MRI is a multiparametric imaging exam that includes MR pulse sequences for CEST-MRI, DW-MRI, DCE-MRI, and DSC-MRI

Also known as: 3-Tesla MRI, 3T MRI