Status:
TERMINATED
FET-PET/MRI for Surgical Assessment of Pediatric Brain Tumors
Lead Sponsor:
University of Alabama at Birmingham
Conditions:
Pediatric Brain Tumors
Eligibility:
All Genders
6-18 years
Phase:
EARLY_PHASE1
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
April 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 29 2023
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT03451123
Start Date
April 23 2018
End Date
August 29 2023
Last Update
December 19 2023
Active Locations (1)
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1
UAB Advanced Imaging Facility
Birmingham, Alabama, United States, 35294