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

Merck Sharp & Dohme (MSD)

Status: Completed

Conditions: Glioma

Study type: Observational

Funder types: Industry

Identifiers

NCT01138813

0000-145

145

2010_027

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

8 participants in 1 patient group

1

Description:

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