Fludeoxyglucose F 18 Positron Emission Tomography and Magnetic Resonance Perfusion Imaging in Patients With Neurofibromatosis 1 and Plexiform Neurofibroma

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 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

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