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

Completed

• Conditions: Glioma

• Registration Number: NCT01138813
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Primary Completion: 2010-02
• Study Completion: 2010-02
• Study First Submitted: 2010-06-04
• Study First Submitted QC: 2010-06-04
• Study First Posted: 2010-06-07
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-09
• Last Update Posted: 2015-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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 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
The within day and between day standard deviations for each metabolite	90 minutes