3T MRI Biomarkers of Glioma Treatment Response
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.
Adult Anaplastic Astrocytoma
Adult Anaplastic Ependymoma
Adult Anaplastic Oligodendroglioma
Adult Giant Cell Glioblastoma
Recurrent Adult Brain Tumor
Device: 3-Tesla magnetic resonance imaging
Drug: IV administration of gadolinium-containing contrast agent
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Early Detection of Glioma Treatment Response Using MRI-Based Biomarkers|
- Best Response [ Time Frame: On‐treatment date to date of disease progression (up to 12 weeks) ] [ Designated as safety issue: No ]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.
- Progression Free Survival (PFS) [ Time Frame: On‐study date to lesser of date of progression or date of death from any cause (assessed at 6 months) ] [ Designated as safety issue: No ]Estimated probable duration of life without disease progression, from on‐study date to earlier of progression date or date of death from any cause, using the Kaplan‐Meier method with censoring. Disease progression is defined under RECIST v1.1 as >=20% increase in sum of longest diameters (LD) of target lesions, unequivocal progression of non‐target lesions, or appearance of new lesions.
- Changes in quantitative MRI-based biomarkers sensitive to tumor protein content, tumor perfusion and hemodynamics [ Time Frame: Baseline to within 4 weeks after on-treatment date ] [ Designated as safety issue: No ]
Evaluation of the following biological imaging metrics:
- Amide proton transfer asymmetry (APTasym) from CEST
- Apparent diffusion coefficient (ADC) from DW-MRI
- Volume transfer constant (Ktrans), extravascular extracellular volume fraction (ve), and plasma volume fraction (vp) from DCE-MRI
- Cerebral blood volume (CBV), cerebral blood flow (CBF) and mean transit time (MTT) from DSC-MRI Both conventional anatomic MRI and quantitative MRI sequences will be used in a single "hybrid" imaging exam to be conducted pre-treatment, early after treatment, and at a follow-up time point long
- Changes in quantitative MRI-based biomarkers using 3.0 Tesla (3T) biomarkers [ Time Frame: Baseline to within 4 weeks after on-treatment date ] [ Designated as safety issue: No ]
3T MRI techniques, that can supplement existing high-resolution anatomic imaging, will be performed to aid clinical decision-making for patients diagnosed with high-grade glioma. These techniques include:
- Chemical Exchange Saturation Transfer (CEST)4
- Diffusion Weighted MRI (DWI, or DW-MRI)5,6
- Dynamic Contrast Enhanced MRI (DCE-MRI)7
- Dynamic Susceptibility Contrast MRI (DSC-MRI)8
|Study Start Date:||May 2012|
|Estimated Study Completion Date:||May 2018|
|Estimated Primary Completion Date:||November 2017 (Final data collection date for primary outcome measure)|
Experimental: 3-Tesla magnetic resonance imaging
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 imaging
3-Tesla MRI is a multiparametric imaging exam that includes MR pulse sequences for CEST-MRI, DW-MRI, DCE-MRI, and DSC-MRI
Other Names:Device: CEST-MRI
Other Name: chemical exchange saturation transfer MRIDevice: DW-MRI
Other Name: diffusion-weighted MRIDevice: DCE-MRI
Other Name: dynamic contrast-enhanced MRIDevice: DSC-MRI
Other Name: dynamic susceptibility contrast MRIDrug: IV administration of gadolinium-containing contrast agent
Gadolinium-containing paramagnetic contrast agent (Magnevist®; Berlex Lab, Wayne, New Jersey) in delivered via intravenous (IV) infusion to achieve DCE and DSC contrast
I. To correlate treatment-induced changes in quantitative MRI-based biomarkers—specifically, those sensitive to tumor protein content (amide proton transfer asymmetry [APTasym] from chemical exchange saturation transfer [CEST]), cellularity (apparent diffusion coefficient [ADC] from diffusion-weighted imaging [DWI]), and blood flow (volume transfer constant [K^trans] from dynamic contrast-enhanced [DCE]; cerebral blood flow [CBF] from dynamic susceptibility contrast [DSC])—with treatment-induced changes in tumor size, measured via standard anatomic MRI.
II. To correlate treatment-induced changes in the above quantitative MRI endpoints with patient progression-free survival (PFS).
Patients undergo measurement of tumor protein content using CEST-MRI, cellularity using DWI-MRI, and blood flow using DCE-MRI and DSC-MRI within 2 weeks of treatment and at 2 and 4 weeks after initiation of treatment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01996527
|Contact: Vanderbilt-Ingram Clinical Trial Information Program||800-811-8480|
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center||Recruiting|
|Nashville, Tennessee, United States, 37232|
|Contact: Chad Quarles 615-322-6215 email@example.com|
|Principal Investigator: Chad Quarles|
|Principal Investigator:||Chad Quarles||Vanderbilt-Ingram Cancer Center|