Clinical trial NCT01138813: Development of Magnetic Resonance Spectroscopy (MRS) Biomarkers of Tumor Metabolism (MK-0000-145)
Official title: Development of Magnetic Resonance Spectroscopy (MRS) Biomarkers of Tumor Metabolism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glioma
Keywords: magnetic resonance spectroscopy (MRS)
lactate editing
metabolite content
glioma
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2010-06-07
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female patients aged 18-70 years old with newly diagnosed operable glioma of grade II or higher

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.


Eligibility criteria: 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

Primary outcomes:
measure: The test-retest repeatability of lactate and other metabolites when measured by multi-voxel MRSI in tumor tissue
timeFrame: 90 minutes
measure: The test-retest repeatability of lactate and other metabolites when measured by single voxel MRS
timeFrame: 90 minutes
Secondary outcomes:
measure: The geometric mean fold rise (GMFR) in the concentrations of lactate and each of the other metabolites for tumor/normal tissue
timeFrame: 90 minutes
measure: The test-retest repeatability of lactate and other metabolites when measured by multi-voxel MRSI in normal tissue
timeFrame: 90 minutes
measure: True geometric mean ratio (GMR) of the MRSI/SV MRS concentration values
timeFrame: 90 minutes
measure: The mean levels of each of the metabolites will be summarized by tumor grade and type
timeFrame: 90 minutes
measure: The correlation between in vivo (measured by MRSI) and in vitro levels of lactate and other metabolites in tumors
timeFrame: 90 minutes
measure: The within day and between day standard deviations for each metabolite
timeFrame: 90 minutes
Other outcomes:
Locations:
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: McLean MA, Sun A, Bradstreet TE, Schaeffer AK, Liu H, Iannone R, Herman G, Railkar RA, Joubert I, Gillard JH, Price SJ, Griffiths JR. Repeatability of edited lactate and other metabolites in astrocytoma at 3T. J Magn Reson Imaging. 2012 Aug;36(2):468-75. doi: 10.1002/jmri.23673. Epub 2012 Apr 25.