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Metabolic Imaging for Glioblastoma

Phase 1 & 2

Recruiting

Led By Benjamin Ellingson, PhD

Research Sponsored by Jonsson Comprehensive Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age > 18

Patients with newly diagnosed or recurrent glioblastoma clinically indicated for resective surgery

Must not have

Subjects with severely compromised renal function (GFR < 30).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up two years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new imaging technique to measure glycolysis in brain tumors. Measures of pH, RNA, proteins, and enzymes will be taken and compared.

Who is the study for?

This trial is for adults over 18 with new or returning glioblastoma who are scheduled for tumor removal surgery. It's not suitable for those unable to undergo MRI or PET scans, have metal implants that could be hazardous in scans, have severe kidney issues (GFR < 30), or extreme claustrophobia.

What is being tested?

The study is testing a novel imaging technique combining MRI and PET to measure glycolysis in brain tumors. Researchers will compare images with actual tissue samples from surgeries to see how well the imaging reflects tumor metabolism.

What are the potential side effects?

Since this trial involves standard imaging procedures and biopsies already planned as part of treatment, side effects may include typical risks associated with these processes such as discomfort at biopsy site, allergic reactions to contrast agents used in scans, and potential complications from sedation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am older than 18 years.

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I have a new or returning glioblastoma and need surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My kidney function is severely reduced.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ two years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~two years

This trial's timeline: 3 weeks for screening, Varies for treatment, and two years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Glycolytic Index

Immunohistochemistry Expression of Glycolytic Molecules

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Arm I en vivo Glycolic Index measurementExperimental Treatment1 Intervention

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.

0 / 3Eligibility criteria met