---
title: Development of Magnetic Resonance Spectroscopy (MRS) Biomarkers of Tumor Metabolism (MK-0000-145)
nct_id: NCT01138813
overall_status: COMPLETED
sponsor: Merck Sharp & Dohme LLC
study_type: OBSERVATIONAL
primary_condition: Glioma
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01138813.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01138813"
ct_last_update_post_date: 2015-10-12
last_seen_at: "2026-05-12T06:08:12.413Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Development of Magnetic Resonance Spectroscopy (MRS) Biomarkers of Tumor Metabolism (MK-0000-145)

**Official Title:** Development of Magnetic Resonance Spectroscopy (MRS) Biomarkers of Tumor Metabolism

**NCT ID:** [NCT01138813](https://clinicaltrials.gov/study/NCT01138813)

## Key Facts

- **Status:** COMPLETED
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 8
- **Lead Sponsor:** Merck Sharp & Dohme LLC
- **Conditions:** Glioma
- **Start Date:** 2009-03
- **Completion Date:** 2010-02
- **CT.gov Last Update:** 2015-10-12

## Brief 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 70 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

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

## Primary Outcomes

- **The test-retest repeatability of lactate and other metabolites when measured by multi-voxel MRSI in tumor tissue** _(time frame: 90 minutes)_
- **The test-retest repeatability of lactate and other metabolites when measured by single voxel MRS** _(time frame: 90 minutes)_

## Secondary Outcomes

- **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)_
- **The test-retest repeatability of lactate and other metabolites when measured by multi-voxel MRSI in normal tissue** _(time frame: 90 minutes)_
- **True geometric mean ratio (GMR) of the MRSI/SV MRS concentration values** _(time frame: 90 minutes)_
- **The mean levels of each of the metabolites will be summarized by tumor grade and type** _(time frame: 90 minutes)_
- **The correlation between in vivo (measured by MRSI) and in vitro levels of lactate and other metabolites in tumors** _(time frame: 90 minutes)_
- **The within day and between day standard deviations for each metabolite** _(time frame: 90 minutes)_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01138813.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01138813*  
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