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

NCT ID: NCT01138813

Last Updated: 2015-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Glioma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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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.

Reference Type RESULT
PMID: 22535478 (View on PubMed)

Other Identifiers

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145

Identifier Type: -

Identifier Source: secondary_id

2010_027

Identifier Type: -

Identifier Source: secondary_id

0000-145

Identifier Type: -

Identifier Source: org_study_id

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