Biologic Association Between Metabolic Magnetic Resonance-positron Emission Tomograph (MR-PET) and Tissue Measures of Glycolysis in Brain Tumors of Infiltrating Glioblastoma Cells

NCT06059690 | Recruiting Phase 1 DMC FDA Device

• 1 other identifier: 21-002007
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this project is to validate a new combined MRI and PET imaging technique as a biomarker or measure of glycolysis in brain tumors. To accomplish this, the investigators propose obtaining image-guided measures of tissue pH and biopsied tissue in tumor areas selected for bulk resection surgery. Investigators will then correlate the imaging measurements with pH, RNA expression, protein expression, and bioenergetics measurements of key glycolytic enzymes.

Conditions

Glioblastoma Multiforme; Glycolytic Index; Epidermal Growth Factor Receptor

Outcome Measures

Primary Outcomes (2)

• Glycolytic Index

  The Glycolytic Index (GI), ranging from 0 to \~1, will be quantified using a combination of FDG PET and MRI measurements. GI is defined as elevated glucose uptake (18F-FDG standard uptake with respect to lean body mass, SUL), elevated tumor acidity (MTRasym @ 3ppm or MTRRex), and lower oxygen utilization (relative cerebral metabolic rate of oxygen, rCMRO2, defined as R2' x rCBF/rCBV from oxygen-sensitive SAGE-EPI and DSC perfusion), normalized to cell density (using ADC from diffusion MRI, which is inversely proportional to cell density). Average GI within the biopsy area prior to biopsy will be correlated with MCT expression within the sample based on immunohistochemistry stain density of percentage positive cells as the 1st primary outcome measure."

  two years

• Immunohistochemistry Expression of Glycolytic Molecules

  MCT expression will be quantified within biopsy samples based on immunohistochemistry stain density of percentage positive cells

  two years

Study Arms (1)

Arm I en vivo Glycolic Index measurement

OTHER

All biopsies are acquired for standard of care and according to standard of care procedures. A 13-gauge biopsy needle and plastic cannula will be inserted into the region of interest identified on MRI and PET. The biopsy needle will be removed, and the Softcell® pH probe, consisting of a 1.8mm diameter high quality glass tip and 1.6m long wire, will be guided down the cannula and inserted at least 15mm into the tissue. Recordings will be made for 1 minute to stabilize the reading, then the pH probe will be removed from the region of interest and placed into a saline vial for the next biopsy target.

Diagnostic Test: pH Measurement of in vivo tissue

Interventions

pH Measurement of in vivo tissue DIAGNOSTIC_TEST

The investigator will identify multiple (2-5) 5-8mm diameter spherical targets on GI maps for use in stereotactic pH measurement and biopsy acquisition. All biopsies are acquired for standard of care and according to standard of care procedures. A 13-gauge biopsy needle and plastic cannula will be inserted into the region of interest identified on MRI and PET. The biopsy needle will be removed, and the Softcell® pH probe, consisting of a 1.8mm diameter high quality glass tip and 1.6m long wire, will be guided down the cannula and inserted at least 15mm into the tissue. Recordings will be made for 1 minute to stabilize the reading, then the pH probe will be removed from the region of interest and placed into a saline vial for the next biopsy target. After the pH probe is removed, the biopsy needle will be placed into the cannula and standard-of-care biopsy tissue will be obtained from the same area where pH measurements were recorded.

Arm I en vivo Glycolic Index measurement

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18
• Patients with newly diagnosed or recurrent glioblastoma clinically indicated for resective surgery

You may not qualify if:

• Patients who cannot obtain an MRI or FDG PET scan with contrast
• Those with ferromagnetic implanted devices that might produce a safety hazard (e.g. infusion pumps, pace makers, aneurysm clips, etc.) will be excluded from the study along with subjects with severe claustrophobia or who have severely compromised renal function (GFR \< 30).

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• Nitional institute of Health -National Center for Advancing Translational Sciences: collaborator

Study Sites (1)

University of California at Los Angeles

Los Angeles, California, 90095-1406, United States

RECRUITING

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Benjamin Ellingson, PhD

  University of California at Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raksha Nagaraj

CONTACT

310-794-8995; RNagaraj@mednet.ucla.edu

Saima Chaabane

CONTACT

310-794-8995; schaabane@mednet.ucla.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a single center, prospective surgical study examining the association between imaging measurements and brain tumor tissue features obtained using image-guided biopsies.

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 29, 2023
• Study Start: September 6, 2023
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2028
• Last Updated: October 8, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)