Multiparametic Metabolic and Hypoxic PET/MRI for Disease Assessment in High Grade Glioma
University of Alabama at Birmingham
Summary
This feasibility study will assess the clinical potential of a new imaging approach to detect viable high grade glioma (HGG) in pediatric and adult patients after standard of care radiation therapy (RT) with or without concurrent temozolomide (TMZ). Study participants will undergo simultaneous positron emission tomography/magnetic resonance imaging (PET/MRI) with O-(\[2-\[F-18\]fluoroethyl)-L-tyrosine (FET, amino acid transport) and 1H-1-(3-\[F-18\]fluoro-2-hydroxypropyl)-2-nitroimidazole (FMISO, hypoxia) at the time of standard of care imaging after completion of RT. The presence of viable tumor at this time point will be assessed on a per patient basis. Study participants will be followed clinically and with standard of care (SOC) imaging for up to 2 years after completion of PET/MRI to determine the nature of lesions seen on investigational imaging and to obtain patient outcome data. The imaging data will also be used to develop a semi-automated workflow suitable for implementation in clinical trials and standard of care PET/MRI studies.
Description
Patient recruitment Potential participants will be identified through the UAB and Children's of Alabama (CoA) Neuro-Oncology, Neurosurgery and Radiation Oncology services. Patients seen in UAB clinics and/or discussed in multi-disciplinary neuro-oncology tumor board meetings may be approached to participate in this study. Potential participants can be enrolled from the time that the plan for standard of care therapy is selected through the time of the first standard of care of MRI after radiation therapy. Given that high grade gliomas are much more frequent in adults than children, we expect…
Eligibility
- Age range
- 10–89 years
- Sex
- All
- Healthy volunteers
- No
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 MR…
Interventions
- DrugO-(2-[18F]Fluoroethyl)-L-tyrosine, [18F]-FET with PET/MRI
High grade glioma patients that are planning to undergo radiation therapy (RT) and consent to this study will have up to 3 in-person study visits. The first visit will take up to 2 hours, the second visit will take up to 3 hours, and the third visit will take up to 6 hours. After both imaging visits, there will be a phone call at 24-48 hours after imaging.After confirmation of patient eligibility and consent, the administration of FET and FMISO and related procedures will be performed in the UAB Advanced Imaging Facility (AIF) at the time of first standard of care (SOC) MRI after completion of RT (typically a 4-week interval). Patients enrolled in the study will be followed clinically and with standard of care brain MRI. PFS and OS will be monitored for up to 24 months after completion of FET and FMISO PET/MRI studies. Study participants will not undergo additional study related procedures after completion of the FET-PET/MRI and FMISO-PET/MRI studies.
Locations (2)
- UABBirmingham, Alabama
- UABBirmingham, Alabama