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CompletedNCT01138813MRS TumorUpdated Oct 12, 2015

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

An observational study in Glioma, sponsored by Merck Sharp & Dohme LLC. Completed. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-10-12.

Sponsored by Merck Sharp & Dohme LLC · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
8
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

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Conditions studied

  • Glioma

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Keywords

  • magnetic resonance spectroscopy (MRS)
  • lactate editing
  • metabolite content
  • glioma
03

In context

Glioma

1,397 studies on the registry are indexed under Glioma; 351 are open to participants now.

This study's enrollment of 8 is below the median of 88 across 238 observational studies indexed under Glioma.

Browse Glioma studies →

Lead sponsor

Merck Sharp & Dohme LLC is the lead sponsor of 2,114 studies on the registry; 133 are open to participants now.

Of its 489 completed or terminated interventional studies of FDA-regulated products, 362 (74%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
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

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
8 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • 1

    Male and female patients aged 18-70 years old with newly diagnosed operable glioma of grade II or higher

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What researchers measure

Primary outcomes

  1. The test-retest repeatability of lactate and other metabolites when measured by multi-voxel MRSI in tumor tissue

    Time frame: 90 minutes

  2. The test-retest repeatability of lactate and other metabolites when measured by single voxel MRS

    Time frame: 90 minutes

Secondary outcomes

  1. The geometric mean fold rise (GMFR) in the concentrations of lactate and each of the other metabolites for tumor/normal tissue

    Time frame: 90 minutes

  2. The test-retest repeatability of lactate and other metabolites when measured by multi-voxel MRSI in normal tissue

    Time frame: 90 minutes

  3. True geometric mean ratio (GMR) of the MRSI/SV MRS concentration values

    Time frame: 90 minutes

  4. The mean levels of each of the metabolites will be summarized by tumor grade and type

    Time frame: 90 minutes

  5. The correlation between in vivo (measured by MRSI) and in vitro levels of lactate and other metabolites in tumors

    Time frame: 90 minutes

  6. The within day and between day standard deviations for each metabolite

    Time frame: 90 minutes

07

Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 22535478 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 12, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01138813
Lead sponsor
Merck Sharp & Dohme LLC
Responsible party
Sponsor
First posted
Jun 7, 2010
Start date
Mar 2009
Primary completion
Feb 2010
Completion
Feb 2010
Last update
Oct 12, 2015

Study contacts

Medical Monitor
study director · Merck Sharp & Dohme LLC

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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