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
  Purpose

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.


Condition
Glioma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Development of Magnetic Resonance Spectroscopy (MRS) Biomarkers of Tumor Metabolism

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

Tissue


Enrollment: 8
Study Start Date: March 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Male and female patients aged 18-70 years old with newly diagnosed operable glioma of grade II or higher

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01138813

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01138813     History of Changes
Other Study ID Numbers: 0000-145, 145, 2010_027
Study First Received: June 4, 2010
Last Updated: November 12, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Merck Sharp & Dohme Corp.:
magnetic resonance spectroscopy (MRS)
lactate editing
metabolite content
glioma

ClinicalTrials.gov processed this record on September 22, 2014