Using Positron Emission Tomography to Predict Intracranial Tumor Growth in Neurofibromatosis Type II Patients
|ClinicalTrials.gov Identifier: NCT01222728|
Recruitment Status : Completed
First Posted : October 18, 2010
Last Update Posted : April 20, 2018
|First Submitted Date||October 15, 2010|
|First Posted Date||October 18, 2010|
|Last Update Posted Date||April 20, 2018|
|Study Start Date||September 22, 2010|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures
||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.|
|Original Primary Outcome Measures||Not Provided|
|Change History||Complete list of historical versions of study NCT01222728 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures
||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...|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Outcome Measures||Not Provided|
|Original Other Outcome Measures||Not Provided|
|Brief Title||Using Positron Emission Tomography to Predict Intracranial Tumor Growth in Neurofibromatosis Type II Patients|
|Official Title||Using Positron Emission Tomography (PET) to Predict Intracranial Tumor Growth in Neurofibromatosis Type II (NF2) Patients|
- 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.
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.
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.
|Study Design||Time Perspective: Prospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Original Estimated Enrollment
|Study Completion Date||June 3, 2015|
|Primary Completion Date||Not Provided|
|Ages||18 Years to 50 Years (Adult)|
|Accepts Healthy Volunteers||No|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||100193
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )|
|Study Sponsor||National Institute of Neurological Disorders and Stroke (NINDS)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||June 3, 2015|