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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
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

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.

Condition or disease Intervention/treatment
Neurofibromatosis Type 1 Precancerous Condition Radiation: fludeoxyglucose F 18 Radiation: gadopentetate dimeglumine

Detailed Description:


  • 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)
Primary Purpose: Diagnostic
Official Title: Novel Imaging Modalities For Plexiform Neurofibromas
Study Start Date : April 2002
Primary Completion Date : May 2011
Study Completion Date : May 2011

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 25 and under

Performance status

  • Not specified

Life expectancy

  • Not specified


  • Not specified


  • Not specified


  • Not specified


  • Not pregnant or nursing
  • Negative pregnancy test


Biologic therapy

  • Not specified


  • 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


  • At least 6 weeks since prior radiotherapy (stratum 2)


  • Prior surgery for progressive plexiform neurofibroma allowed if incompletely resected and measurable disease remains (stratum 2)

Information from the National Library of Medicine

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
Sponsors and Collaborators
Children's Hospital of Philadelphia
Study Chair: Michael Fisher, MD Children's Hospital of Philadelphia

Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00060008     History of Changes
Other Study ID Numbers: 2001-8-2543
CHP-724 ( Other Identifier: Children's Hospital of Philadelphia )
First Posted: May 7, 2003    Key Record Dates
Results First Posted: April 4, 2014
Last Update Posted: April 4, 2014
Last Verified: April 2014

Keywords provided by Children's Hospital of Philadelphia:
neurofibromatosis type 1
plexiform neurofibroma

Additional relevant MeSH terms:
Neurofibromatosis 1
Precancerous Conditions
Nerve Sheath Neoplasms
Neurofibroma, Plexiform
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplastic Syndromes, Hereditary
Neurocutaneous Syndromes
Nervous System Diseases
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Peripheral Nervous System Diseases
Neuromuscular Diseases
Peripheral Nervous System Neoplasms
Nervous System Neoplasms
Fluorodeoxyglucose F18
Molecular Mechanisms of Pharmacological Action