Recruiting
Phase 1
Phase 2

Observational Study

Sponsor:

Jonsson Comprehensive Cancer Center

Code:

NCT06059690

Conditions

Glioblastoma Multiforme

Glycolytic Index

Epidermal Growth Factor Receptor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

pH Measurement of in vivo tissue

Study Details

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

Study ID

NCT06059690

Start date

Sep 6, 2023

Status verified date

Oct, 2025

Completion date

Sep 30, 2028

Anticipated

Primary completion date

Sep 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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).

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

other: Arm I en vivo Glycolic Index measurement

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.

Interventions

pH Measurement of in vivo tissue

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.

Primary outcome measure

  • Glycolytic Index [ Time Frame: two years ]
  • Immunohistochemistry Expression of Glycolytic Molecules [ Time Frame: two years ]

Central Contacts and Locations

Central contacts

Raksha Nagaraj

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

Saima Chaabane

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

Locations

University of California at Los Angeles

Recruiting

Los Angeles, California, United States, 90095-1406

Contacts

Raksha Nagaraj

310-481-7555RNagaraj@mednet.ucla.edu

Saima Chaabane

310-481-7555schaabane@mednet.ucla.edu

More Information

Sponsor

Jonsson Comprehensive Cancer Center

Last update posted

Oct 8, 2025

Last verified

Oct, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Jonsson Comprehensive Cancer Center on 2025-10-08.