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NeoplasmsNCT01222728

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

An observational study of Neoplasms and Nervous System Disease, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years
How many people
5 participants
Where
1 siteUnited States
Study dates
22 Sep 2010to 3 Jun 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.
Show all 9Show fewer
  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, 20892

Other trials in United States

About this study

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

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.
Read more

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

STUDY POPULATION: <TAB>

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.

DESIGN:

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.

OUTCOME MEASURES:

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.

Keywords
PET Imaging, Vestibular Schwannoma, Neurofibromatosis, Neurofibromatosis Type 2, NF2
Medical subject headings
Neoplasms, Nervous System Diseases, Vestibular Diseases, Neuroma, Acoustic, Neurofibromatoses, Neurofibromatosis 2

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

  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...

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2010 (estimated)
  2. Study start22 Sep 2010
  3. Study completion3 Jun 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Time perspective
Prospective
Enrolment
5 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01222728
Sponsor's protocol ID
100193
Other IDs
10-N-0193
Status last verified
3 Jun 2015
First submitted
15 Oct 2010
Last updated
17 Dec 2019
Results posted
No

Publications

  • 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.

    PubMed 9831165

  • 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.

    PubMed 8656953

  • 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.

    PubMed 11838793

Questions about this trial

What is this clinical trial studying?

An observational study of Neoplasms and Nervous System Disease, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary 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.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01222728, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2019.

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