GliomaMRS TumorNCT01138813
Development of Magnetic Resonance Spectroscopy (MRS) Biomarkers of Tumor Metabolism (MK-0000-145)
An observational study of Glioma, run by Merck Sharp & Dohme LLC.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glioma
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- Mar 2009to Feb 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Male and female patients aged 18-70 years old with newly diagnosed operable glioma of grade II or higher
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
- Conditions
- Glioma
- Keywords
- magnetic resonance spectroscopy (MRS), lactate editing, metabolite content, glioma
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Male and female patients aged 18-70 years old with newly diagnosed operable glioma of grade II or higher |
What is being measured
The primary outcome is the main question the study is designed to answer.
The test-retest repeatability of lactate and other metabolites when measured by multi-voxel MRSI in tumor tissue
Measured: 90 minutes
The test-retest repeatability of lactate and other metabolites when measured by single voxel MRS
Measured: 90 minutes
Secondary outcomes (6)
The geometric mean fold rise (GMFR) in the concentrations of lactate and each of the other metabolites for tumor/normal tissue
Measured: 90 minutes
The test-retest repeatability of lactate and other metabolites when measured by multi-voxel MRSI in normal tissue
Measured: 90 minutes
True geometric mean ratio (GMR) of the MRSI/SV MRS concentration values
Measured: 90 minutes
The mean levels of each of the metabolites will be summarized by tumor grade and type
Measured: 90 minutes
The correlation between in vivo (measured by MRSI) and in vitro levels of lactate and other metabolites in tumors
Measured: 90 minutes
The within day and between day standard deviations for each metabolite
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2010 (estimated)
- Study startMar 2009
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01138813
- Sponsor's protocol ID
- 0000-145
- Other IDs
- 145, 2010_027
- Acronym
- MRS Tumor
- Status last verified
- Oct 2015
- First submitted
- 4 Jun 2010
- Last updated
- 12 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22535478
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Magnetic Resonance Spectroscopy (MRS) Biomarkers of Tumor Metabolism
- ClinicalTrials.gov ID
- NCT01138813
- Acronym / sponsor ID
- MRS Tumor / 0000-145
- Conditions
- Glioma
- Keywords
- magnetic resonance spectroscopy (MRS), lactate editing, metabolite content, glioma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Mar 2009
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 7 Jun 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Male and female patients aged 18-70 years old with newly diagnosed operable glioma of grade II or higher |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Male and female patients aged 18-70 years old with newly diagnosed operable glioma of grade II or higher
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
6 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2015.
- Results publication: PubMed 22535478McLean 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.
Related trials for Glioma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Glioblastoma
RecruitingPhase 3
A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma
Low Grade Astrocytoma, Low Grade Glioma
RecruitingPhase 3
Beginning Radiation Immediately With GammaTile at GBM Excision Versus Standard of Care
Glioblastoma
RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
An observational study of Glioma, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01138813, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2015.