Status:
COMPLETED
Using Positron Emission Tomography to Predict Intracranial Tumor Growth in Neurofibromatosis Type II Patients
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Neoplasms
Nervous System Disease
Eligibility:
All Genders
18-50 years
Brief Summary
Background: * Neurofibromatosis type II (NF2) is associated with tumors of the nerves, brain, and spinal cord. Most people with NF2 develop vestibular schwannomas, or tumors on the hearing and balanc...
Detailed Description
OBJECTIVE: The objective of this prospective observational study of intracranial tumors in patients with neurofibromatosis type 2 (NF2) is to gain insight into the use of 18F-fluoro-deoxyglucose (FDG...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Clinical diagnosis of NF2 by established clinical criteria or genetic testing.
- Age 18 to 50.
- A minimum of 3 intracranial tumors (meningiomas and/or VSs) measuring = or \> 1cm in size, including:
- At least one unoperated VS \> 1 cm in size AND
- At least one unoperated meningioma \> 1 cm in size
- No pregnancy or intent to become pregnant, with proper use of contraception for the duration of the study.
- Normal liver enzymes: tests should be completed within 14 days before injection of the radiopharmaceutical; SGOT, SGPT \<5x ULN; bilirubin less than or equal to 2x ULN
- If prior radiation therapy to the tumor: \>2 years must have passed after radiotherapy administration and tumor must demonstrate growth after radiotherapy (signifying a viable tumor for study is present)
- If prior chemotherapy: must have completed chemotherapy \>6 months prior to enrollment to allow washout of chemotherapeutic agent
- EXCLUSION CRITERIA:
- Clinically unstable condition that precludes serial clinical and imaging evaluation (i.e. Class 3 congestive heart failure, severe chronic renal insufficiency, severe chronic obstructive pulmonary disease).
- Contraindication to MRI scanning, including pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pump, or shrapnel fragments
- Severe chronic renal insufficiency (glomerular filtration rate \< 30 mL/min/1.73 m2), hepatorenal syndrome or post-liver transplantation.
Exclusion
Key Trial Info
Start Date :
September 22 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 3 2015
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT01222728
Start Date
September 22 2010
End Date
June 3 2015
Last Update
December 17 2019
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892