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

Glioma Clinical Trial

— MRS Tumor  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01138813
• Other study ID #: 0000-145
• Secondary ID: 1452010_027
• Status: Completed
• Phase: N/A
• First received: June 4, 2010
• Last updated: October 9, 2015
• Start date: March 2009
• Est. completion date: February 2010

Study information

• Verified date: October 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glioma

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The test-retest repeatability of lactate and other metabolites when measured by multi-voxel MRSI in tumor tissue		90 minutes	No
Primary	The test-retest repeatability of lactate and other metabolites when measured by single voxel MRS		90 minutes	No
Secondary	The geometric mean fold rise (GMFR) in the concentrations of lactate and each of the other metabolites for tumor/normal tissue		90 minutes	No
Secondary	The test-retest repeatability of lactate and other metabolites when measured by multi-voxel MRSI in normal tissue		90 minutes	No
Secondary	True geometric mean ratio (GMR) of the MRSI/SV MRS concentration values		90 minutes	No
Secondary	The mean levels of each of the metabolites will be summarized by tumor grade and type		90 minutes	No
Secondary	The correlation between in vivo (measured by MRSI) and in vitro levels of lactate and other metabolites in tumors		90 minutes	No
Secondary	The within day and between day standard deviations for each metabolite		90 minutes	No