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Using Positron Emission Tomography (PET) to Predict Intracranial Tumor Growth in Neurofibromatosis Type II (NF2) Patients

18 Years
50 Years
Open (Enrolling)
Neoplasms, Nervous System Disease, Vestibular Disease

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Trial Information

Using Positron Emission Tomography (PET) to Predict Intracranial Tumor Growth in Neurofibromatosis Type II (NF2) Patients


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) and 3'-deoxy-3'-18F-fluorothymidine (FLT) positron emission
tomography (PET)/computed tomography (CT) as a predictive measure of future tumor growth


Twelve patients, ages 18-50, with a clinical or genetic diagnosis of NF2 and harboring at
least 3 unoperated intracranial tumors (meningiomas and/or vestibular schwannomas) will
participate in this study.


Study participants will be evaluated with a thorough physical and neurologic examination
upon enrollment. This initial outpatient evaluation will include contrast-enhanced magnetic
resonance imaging (MRI) of the brain, FDG-PET/CT and FLT-PET/CT scans.

Subjects will be followed as outpatients for two years, during which time MRI evaluation
will be performed every six months.


Based on data derived from this study, we hope to correlate FDG-PET/CT and FLT-PET/CT scans
with metabolic activity and cellular proliferation within tumors. These findings will help
us better forecast tumor growth and senescence. These findings should permit the safer
treatment of the subset of tumors that will grow and cause symptoms and avoid the
unnecessary treatment of lesions that will remain stable (not requiring treatment) in these

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:

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.

Type of Study:


Study Design:

Time Perspective: Prospective

Outcome Measure:

To determine whether FDG and/or FLT uptake correlate with growth rate of meningiomas and Vestibular Schwannomas (VSs) in NF2 patients, and can be used to predict their future growth pattern.

Principal Investigator

Ashok R Asthagiri, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Institute of Neurological Disorders and Stroke (NINDS)


United States: Federal Government

Study ID:




Start Date:

September 2010

Completion Date:

Related Keywords:

  • Neoplasms
  • Nervous System Disease
  • Vestibular Disease
  • PET Imaging
  • Vestibular Schwannoma
  • Neurofibromatosis
  • Neurofibromatosis Type 2
  • NF2
  • Neoplasms
  • Nervous System Diseases
  • Neurofibromatoses
  • Neurofibromatosis 1
  • Osteitis Fibrosa Cystica
  • Neurofibromatosis 2
  • Vestibular Diseases
  • Brain Neoplasms



National Institutes of Health Clinical Center, 9000 Rockville PikeBethesda, Maryland  20892