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

NCT01222728 | Completed

• 2 other identifiers: 10019310-N-0193
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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 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. Objectives: \- To use magnetic resonance imaging and positron emission tomography to better understand the growth of brain tumors in people with neurofibromatosis type II. Eligibility: \- Individuals between 18 and 50 years of age who have been diagnosed with NF2 and have at least three untreated intracranial tumors. Design:
• 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.

Conditions

Nervous System Disease; Neoplasms; Vestibular Disease

Keywords

PET Imaging; Vestibular Schwannoma; Neurofibromatosis; Neurofibromatosis Type 2; NF2

Outcome Measures

Primary Outcomes (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 Outcomes (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...

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Chen JM, Houle S, Ang LC, Commins D, Allan K, Nedzelski J, Rowed D. A study of vestibular schwannomas using positron emission tomography and monoclonal antibody Ki-67. Am J Otol. 1998 Nov;19(6):840-5.

  PMID: 9831165 BACKGROUND

• Abaza MM, Makariou E, Armstrong M, Lalwani AK. Growth rate characteristics of acoustic neuromas associated with neurofibromatosis type 2. Laryngoscope. 1996 Jun;106(6):694-9. doi: 10.1097/00005537-199606000-00007.

  PMID: 8656953 BACKGROUND

• Baser ME, Makariou EV, Parry DM. Predictors of vestibular schwannoma growth in patients with neurofibromatosis Type 2. J Neurosurg. 2002 Feb;96(2):217-22. doi: 10.3171/jns.2002.96.2.0217.

  PMID: 11838793 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Nervous System Diseases; Vestibular Diseases; Neuroma, Acoustic; Neurofibromatoses; Neurofibromatosis 2

Condition Hierarchy (Ancestors)

Labyrinth Diseases; Ear Diseases; Otorhinolaryngologic Diseases; Neurilemmoma; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neuroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Cranial Nerve Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Peripheral Nervous System Neoplasms; Vestibulocochlear Nerve Diseases; Retrocochlear Diseases; Otorhinolaryngologic Neoplasms; Cranial Nerve Diseases; Neurofibroma; Neoplastic Syndromes, Hereditary; Neurocutaneous Syndromes; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• John D Heiss, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 15, 2010
• First Posted: October 18, 2010
• Study Start: September 22, 2010
• Study Completion: June 3, 2015
• Last Updated: December 17, 2019

Record last verified: 2015-06-03

Locations

US (1)