FET-PET/MRI for Surgical Assessment of Pediatric Brain Tumors
The primary objectives of this study are: 1. Determine the percentage of patients whose surgical plan would change with FET-PET/MRI compared to MRI alone. 2. Determine the percentage of patients who have residual tumor after surgery detected with FET-PET/MRI. A secondary objective of this study is: 1) Perform preliminary correlations between the pre- and post-surgical metabolic tumor volumes measured with FET-PET/MRI to progression free survival.
- Pediatric Brain Tumors
- Eligible Ages
- Between 6 Years and 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
- Patient must have a known or suspected primary brain tumor with a non-enhancing component with planned standard of care surgical resection. Patients with newly diagnosed or recurrent brain tumors are eligible.
- Tumors with non-enhancing regions will be defined as T2/FLAIR hyperintensity extending at least 0.5 cm beyond areas of enhancement as assessed by MRI.
- Patient must be 18 years of age or younger at the time of study enrollment.
- Patient must have measurable disease defined as tumor measurable in two perpendicular dimensions on MRI greater than 1 cm.
- Patient must have a life expectancy greater than 8 weeks.
- Patient must be able to undergo FET-PET/MRI without sedation.
- Females with childbearing potential must have a negative urine β-hCG test on the day of procedure or a serum hCG test within 48 hours prior to the administration FET. Females who have not reached menarche will not require pregnancy testing.
- Patient must not be receiving an investigational or standard of care anti-cancer drug within 6 months prior to the FET-PET/MRI study.
- Patient must not have received radiation therapy within the past 6 months.
- Patient must not have a contraindication to contrast-enhanced MRI (e.g. renal insufficiency, incompatible implant).
- Patient must not be pregnant or breast feeding.
- Patient must not have been treated for another cancer within 5 years with the exception of cutaneous basal cell carcinoma or squamous cell carcinoma.
- Patients must not have a history of brain metastases.
- Early Phase 1
- Study Type
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Single group assignment
- Primary Purpose
- None (Open Label)
|O-(2-[F-18]FET)-L-tyrosine (FET) for brain PET/MRI||
- University of Alabama at Birmingham
Study ContactJonathan McConathy, MD, PhD