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Using Positron Emission Tomography to Predict Intracranial Tumor Growth in Neurofibromatosis Type II Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01222728
Recruitment Status : Completed
First Posted : October 18, 2010
Last Update Posted : December 17, 2019
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )

Brief Summary:


  • 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 balance nerves. As they grow, vestibular schwannomas can cause hearing loss and balance problems. If they grow very large they can cause more serious problems, such as seizures, loss of eyesight, weakness, speech problems, and problems with the sense of touch. More research is needed into NF2 because researchers do not completely understand why these tumors occur or what makes them grow over time.
  • Currently, tumor size is measured with magnetic resonance imaging (MRI) scans. However, MRI scans cannot predict how fast a tumor will grow. By using positron emission tomography (PET) scanning, researchers hope to be able to predict sudden growth spurts of tumors associated with NF2 and develop better treatment methods for this type of cancer.


- To use magnetic resonance imaging and positron emission tomography to better understand the growth of brain tumors in people with neurofibromatosis type II.


- Individuals between 18 and 50 years of age who have been diagnosed with NF2 and have at least three untreated intracranial tumors.


  • This study requires an initial set of outpatient visits to the NIH Clinical Center that will last 7 to 10 days.
  • Participants will have a physical and neurological examination and blood tests at the first visit. Participants will then have the following imaging studies to examine the tumors:
  • MRI scans of the brain
  • PET scans of the brain, combined with a computed tomography (CT) scan. The PET scans will be performed on separate days. Different contrast agents will be used for both scans, so researchers will inform participants if they need to fast or follow other procedures before having the scan.
  • After the initial imaging studies, participants will have additional MRI scans every 6 months for 2 years to track tumor growth.

Condition or disease
Neoplasms Nervous System Disease Vestibular Disease

Detailed Description:


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 patterns.


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 patients.

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Study Type : Observational
Actual Enrollment : 5 participants
Time Perspective: Prospective
Official Title: Using Positron Emission Tomography (PET) to Predict Intracranial Tumor Growth in Neurofibromatosis Type II (NF2) Patients
Study Start Date : September 22, 2010
Study Completion Date : June 3, 2015

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. To characterize glucose metabolism and cellular proliferative activity in meningiomas and VSs in NF2 patients, using FDG and FLT PET/CT imaging. To determine the degree to which glucose metabolism and cell proliferation are coupled in meningioma...

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01222728

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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
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Principal Investigator: John D Heiss, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
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Responsible Party: National Institute of Neurological Disorders and Stroke (NINDS) Identifier: NCT01222728    
Other Study ID Numbers: 100193
First Posted: October 18, 2010    Key Record Dates
Last Update Posted: December 17, 2019
Last Verified: June 3, 2015
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) ):
PET Imaging
Vestibular Schwannoma
Neurofibromatosis Type 2
Additional relevant MeSH terms:
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Neurofibromatosis 1
Neurofibromatosis 2
Vestibular Diseases
Nervous System Diseases
Nerve Sheath Neoplasms
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplastic Syndromes, Hereditary
Neurocutaneous Syndromes
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Peripheral Nervous System Diseases
Neuromuscular Diseases
Peripheral Nervous System Neoplasms
Nervous System Neoplasms
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases
Neuroma, Acoustic
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Vestibulocochlear Nerve Diseases
Retrocochlear Diseases