Fludeoxyglucose F 18 Positron Emission Tomography and Magnetic Resonance Perfusion Imaging in Patients With Neurofibromatosis 1 and Plexiform Neurofibroma
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|ClinicalTrials.gov Identifier: NCT00060008|
Recruitment Status : Terminated (Study was closed early due to poor accrual.)
First Posted : May 7, 2003
Results First Posted : April 4, 2014
Last Update Posted : April 4, 2014
RATIONALE: New imaging procedures such as fludeoxyglucose F 18 positron emission tomography (FDG-PET) and magnetic resonance (MR) perfusion imaging may improve the ability to detect disease progression, help doctors predict a patient's response to treatment, and help plan the most effective treatment.
PURPOSE: This diagnostic trial is studying how well FDG-PET and MR perfusion imaging work in finding disease progression and determining response to treatment in patients with neurofibromatosis 1 and plexiform neurofibroma.
|Condition or disease||Intervention/treatment||Phase|
|Neurofibromatosis Type 1 Precancerous Condition||Radiation: fludeoxyglucose F 18 Radiation: gadopentetate dimeglumine||Not Applicable|
- Determine whether fludeoxyglucose F 18 positron emission tomography (FDG-PET) and MR perfusion studies can predict plexiform neurofibroma growth rates in patients with neurofibromatosis 1.
- Determine whether FDG-PET and MR perfusion studies can predict the likelihood of response in patients who are undergoing investigational treatment for plexiform neurofibromas.
- Identify neuroimaging characteristics that distinguish patients who have responded to therapy from those who have not after completion of treatment.
- Stratum 1: Patients undergo MR perfusion scan with gadopentetate dimeglumine and fludeoxyglucose F 18 positron emission tomography (FDG-PET) at baseline and quantitative MRI evaluation at baseline and 1 year.
- Stratum 2: Patients undergo quantitative MRI, MR perfusion scan with gadopentetate dimeglumine, and FDG-PET at baseline and 1 year.
PROJECTED ACCRUAL: A total of 48 patients (32 for stratum 1 and 16 for stratum 2) will be accrued for this study.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Novel Imaging Modalities For Plexiform Neurofibromas|
|Study Start Date :||April 2002|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||May 2011|
Experimental: 18FDG-PET scan and MR perfusion
Subjects will undergo MRI for quantitative (2D and 3D) evaluation of plexiform neurofibroma size, MR perfusion scan, and fludeoxyglucose (18FDG) PET scan at the time of study entry. Subjects who are treated for plexiform neurofibroma will undergo another 18FDG PET scan after one year of study entry.
Radiation: fludeoxyglucose F 18
Radiation: gadopentetate dimeglumine
- Tumor Progression as Measured by Tumor Area and Volume at 1 Year. [ Time Frame: One year ]We correlated SUVmax and change in tumor volume over the subsequent year
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 ClinicalTrials.gov identifier (NCT number): NCT00060008
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104-4283|
|Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|Study Chair:||Michael Fisher, MD||Children's Hospital of Philadelphia|