Clinical trial · Observational
Development of Magnetic Resonance Spectroscopy (MRS) Biomarkers of Tumor Metabolism (MK-0000-145)
Development of Magnetic Resonance Spectroscopy (MRS) Biomarkers of Tumor Metabolism
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioma | Glioma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- 1
- description
- Male and female patients aged 18-70 years old with newly diagnosed operable glioma of grade II or higher
Primary outcomes (2)
- 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 (6)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTMcLean 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. PMID 22535478