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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01138813
First received: June 4, 2010
Last updated: November 12, 2013
Last verified: November 2013

June 4, 2010
November 12, 2013
March 2009
February 2010   (final data collection date for primary outcome measure)
  • The test-retest repeatability of lactate and other metabolites when measured by multi-voxel MRSI in tumor tissue [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
  • The test-retest repeatability of lactate and other metabolites when measured by single voxel MRS [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01138813 on ClinicalTrials.gov Archive Site
  • 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 ] [ Designated as safety issue: No ]
  • The test-retest repeatability of lactate and other metabolites when measured by multi-voxel MRSI in normal tissue [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
  • True geometric mean ratio (GMR) of the MRSI/SV MRS concentration values [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
  • The mean levels of each of the metabolites will be summarized by tumor grade and type [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
  • The correlation between in vivo (measured by MRSI) and in vitro levels of lactate and other metabolites in tumors [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
  • The within day and between day standard deviations for each metabolite [ Time Frame: 90 minutes ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Development of Magnetic Resonance Spectroscopy (MRS) Biomarkers of Tumor Metabolism (MK-0000-145)
Development of Magnetic Resonance Spectroscopy (MRS) Biomarkers of Tumor Metabolism

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Tissue

Non-Probability Sample

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

Glioma
Not Provided
1
Male and female patients aged 18-70 years old with newly diagnosed operable glioma of grade II or higher
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
February 2010
February 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01138813
0000-145, 145, 2010_027
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP