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|NCT03451123 : FET-PET/MRI for Surgical Assessment of Pediatric Brain Tumors|
|Phase||Early Phase 1|
|Ages||Min: 6 Years Max: 18 Years|
1. 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.
2. 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.
3. Patient must be 18 years of age or younger at the time of study enrollment.
4. Patient must have measurable disease defined as tumor measurable in two perpendicular
dimensions on MRI greater than 1 cm.
5. Patient must have a life expectancy greater than 8 weeks.
6. Patient must be able to undergo FET-PET/MRI without sedation.
7. Females with childbearing potential must have a negative urine ß-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.
1. Patient must not be receiving an investigational or standard of care anti-cancer drug
within 6 months prior to the FET-PET/MRI study.
2. Patient must not have received radiation therapy within the past 6 months.
3. Patient must not have a contraindication to contrast-enhanced MRI (e.g. renal
insufficiency, incompatible implant).
4. Patient must not be pregnant or breast feeding.
5. Patient must not have been treated for another cancer within 5 years with the
exception of cutaneous basal cell carcinoma or squamous cell carcinoma.
6. Patients must not have a history of brain metastases.
|Links||Permanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT03451123
| Link to official Clinicaltrials.gov listing