Development of Magnetic Resonance Spectroscopy (MRS) Biomarkers of Tumor Metabolism (MK-0000-145)

Study Overview
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Brief Summary
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This study will evaluate the test-retest repeatability of lactate and other metabolites measured by single voxel magnetic resonance spectroscopy (MRS) and multi-voxel magnetic resonance spectroscopic imaging experiments (MRSI) in tumor tissue in patients radiographically diagnosed with glioma. These measurements will test whether the concentration of lactate in tumor will be higher than the concentration of lactate in normal tissue of the same patient.

Official Title
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Development of Magnetic Resonance Spectroscopy (MRS) Biomarkers of Tumor Metabolism

Conditions
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Glioma

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients aged 18-70 years old with newly diagnosed operable glioma of grade II or higher which is > 3cm in diameter based on radiographic examination Patients about to receive biopsy or resection of newly diagnosed glioma Exclusion Criteria: Contraindication to magnetic resonance imaging (MRI): e.g. cardiac pacemaker, metallic implants, known contrast allergy, and pregnancy Impaired renal function Current or previous chemotherapy, radiation, or other tumor treatment excluding steroids Tumor location extra-cerebral, temporal, or in close proximity to frontal sinus

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Male and female patients aged 18-70 years old with newly diagnosed operable glioma of grade II or higher | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The test-retest repeatability of lactate and other metabolites when measured by multi-voxel MRSI in tumor tissue |  | 90 minutes | 
| The test-retest repeatability of lactate and other metabolites when measured by single voxel MRS |  | 90 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The geometric mean fold rise (GMFR) in the concentrations of lactate and each of the other metabolites for tumor/normal tissue |  | 90 minutes | 
| The test-retest repeatability of lactate and other metabolites when measured by multi-voxel MRSI in normal tissue |  | 90 minutes | 
| True geometric mean ratio (GMR) of the MRSI/SV MRS concentration values |  | 90 minutes | 
| The mean levels of each of the metabolites will be summarized by tumor grade and type |  | 90 minutes | 
| The correlation between in vivo (measured by MRSI) and in vitro levels of lactate and other metabolites in tumors |  | 90 minutes | 
| The within day and between day standard deviations for each metabolite |  | 90 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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magnetic resonance spectroscopy (MRS), lactate editing, metabolite content, glioma