New imaging approach for assessing high grade glioma after radiation therapy

Multiparametic Metabolic and Hypoxic PET/MRI for Disease Assessment in High Grade Glioma

This study is testing a new imaging method to see if it can help doctors find active high grade glioma in kids and adults after they've had radiation therapy.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 10 Years to 89 Years
• Sex: All
• Sponsor: University of Alabama at Birmingham (other)
• Drugs / interventions: bevacizumab, radiation
• Locations: 2 sites (Birmingham, Alabama and 1 other locations)
• Trial ID: NCT05632562 on ClinicalTrials.gov

What this trial studies

This feasibility study evaluates a novel imaging technique using simultaneous PET/MRI to detect viable high grade glioma (HGG) in pediatric and adult patients following standard radiation therapy, with or without concurrent temozolomide. Participants will undergo imaging with specific tracers to assess tumor viability and will be monitored for up to two years to gather clinical outcomes. The study aims to develop a semi-automated workflow for implementing this imaging approach in clinical practice.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 10 years or older with newly diagnosed grade III or IV glioma who have undergone standard radiation therapy.

Not a fit: Patients with recurrent glioma or those unable to undergo PET/MRI without sedation may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the detection and assessment of high grade glioma, leading to better treatment decisions and outcomes for patients.

How similar studies have performed: While similar imaging approaches have been explored, this specific combination of PET/MRI for high grade glioma assessment is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Histologically confirmed newly diagnosed grade III or grade IV glioma treated with standard of care external beam radiation therapy (RT). For diffuse midline glioma involving the pons (diffuse intrinsic pontine glioma), histological confirmation is not required. Surgical resection of the glioma prior to RT and/or concurrent temozolomide (TMZ) with RT are allowed but not required.
2. 10 years of age or older at the time of enrollment
3. Able to undergo PET/MRI without anesthesia or sedation. Minimal sedation with an anxiolytic such as alprazolam used routinely for SOC MRI is allowed.
4. Females with childbearing potential must have a negative urine β-hCG test on the day of procedure or a serum beta-hCG test within 48 hours prior to the administration of FET or FMISO.
5. ECOG performance score of 2 or better in adults. For patients less than 16 years of age, Modified Lansky score ≥ 60.
6. Life expectancy greater than 12 weeks.

Exclusion Criteria:

1. Recurrent glioma
2. Use of bevacizumab or an investigational therapeutic drug for any indication within 3 months prior to the imaging study.
3. Pregnancy or breast feeding
4. Inability to complete PET/MRI scans.
5. Significant renal dysfunction (estimated GFR \< 30 mL/min)
6. Any condition which may interfere with ability to participate in or complete all study-related activities as assessed by the study team
7. Time interval greater than 12 weeks between the completion of RT and performance of FET and FMISO PET/MRI studies.

Where this trial is running

Birmingham, Alabama and 1 other locations

• UAB — Birmingham, Alabama, United States (NOT_YET_RECRUITING)
• UAB — Birmingham, Alabama, United States (RECRUITING)

Study contacts

• Principal investigator: Jonathan McConathy, MD — University of Alabama at Birmingham
• Study coordinator: Sebastian M Eady, BS

Conditions: High Grade Glioma