Brief Title
Fludeoxyglucose F 18 Positron Emission Tomography and Magnetic Resonance Perfusion Imaging in Patients With Neurofibromatosis 1 and Plexiform Neurofibroma
Official Title
Novel Imaging Modalities For Plexiform Neurofibromas
Brief Summary
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.
Detailed Description
OBJECTIVES: - 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. OUTLINE: - 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
Primary Outcome
Tumor Progression as Measured by Tumor Area and Volume at 1 Year.
Condition
Neurofibromatosis Type 1
Intervention
fludeoxyglucose F 18
Study Arms / Comparison Groups
18FDG-PET scan and MR perfusion
Description: 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Radiation
Estimated Enrollment
18
Start Date
April 2002
Completion Date
May 2011
Primary Completion Date
May 2011
Eligibility Criteria
DISEASE CHARACTERISTICS: - Stratum 1: - Diagnosis of neurofibromatosis 1 (NF1) and plexiform neurofibromas - At high risk for progression, as defined by any of the following: - Anatomic location such that progression carries a high risk of impairment of function, pain, or disfigurement (e.g., neck/mediastinum, paraspinal nerve roots, orbit, and face) - Tumors that the patient, family, or caregiver believes have increased in size within the past year, but appear stable by standard clinical or radiographic measures - No plexiform neurofibromas that are small, cause no pain or functional impairment, or are not likely to cause pain or functional impairment over the succeeding 12 months - Stratum 2: - Diagnosis of NF1 and progressive plexiform neurofibromas - Neurofibroma progression documented by increase in lesion size on MRI - Currently being enrolled on a clinical therapeutic trial at Children's Hospital of Philadelphia PATIENT CHARACTERISTICS: Age - 25 and under Performance status - Not specified Life expectancy - Not specified Hematopoietic - Not specified Hepatic - Not specified Renal - Not specified Other - Not pregnant or nursing - Negative pregnancy test PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Stratum 1: - No prior or concurrent chemotherapy - No concurrent enrollment on a chemotherapy clinical trial - Stratum 2: - At least 4 weeks since prior chemotherapy Endocrine therapy - Not specified Radiotherapy - At least 6 weeks since prior radiotherapy (stratum 2) Surgery - Prior surgery for progressive plexiform neurofibroma allowed if incompletely resected and measurable disease remains (stratum 2)
Gender
All
Ages
N/A - 25 Years
Accepts Healthy Volunteers
No
Contacts
Michael Fisher, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00060008
Organization ID
2001-8-2543
Secondary IDs
CHP-724
Responsible Party
Sponsor
Study Sponsor
Children's Hospital of Philadelphia
Study Sponsor
Michael Fisher, MD, Study Chair, Children's Hospital of Philadelphia
Verification Date
April 2014