Clinical Trial Details
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NCT01222728 : Using Positron Emission Tomography to Predict Intracranial Tumor Growth in Neurofibromatosis Type II Patients
AgesMin: 18 Years Max: 50 Years

- 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:

1. At least one unoperated VS > 1 cm in size AND

2. 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


- 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.
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