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Completed

NCT Number: NCT01138813

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

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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Key information

Conditions

Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

Development of Magnetic Resonance Spectroscopy (MRS) Biomarkers of Tumor Metabolism

Acronym: MRS Tumor

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 7, 2010
Registry last updated
Oct 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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