Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Diagnostic	Active	25 and under	Other	CHP-724 CHP-IRB-2001-8-2543, NCT00060008

Objectives

1. 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.
2. Determine whether FDG-PET and MR perfusion studies can predict the likelihood of response in patients who are undergoing investigational treatment for plexiform neurofibromas.
3. Identify neuroimaging characteristics that distinguish patients who have responded to therapy from those who have not after completion of treatment.

Entry 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

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)

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

Expected Enrollment

A total of 48 patients (32 for stratum 1 and 16 for stratum 2) will be accrued for this study.

Outcomes

Tumor progression as measured by tumor area and volume at 1 year

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.

Trial Contact Information

Trial Lead Organizations

Children's Hospital of Philadelphia

Michael Fisher, MD, Protocol chair		Ph: 215-590-2800

U.S.A.
Pennsylvania
	Philadelphia
	Abramson Cancer Center of the University of Pennsylvania
		Clinical Trials Office - Abramson Cancer Center of the University of Pennsylvania	Ph:  800-474-9892
	Children's Hospital of Philadelphia
		Michael Fisher, MD	Ph:  215-590-3129

Registry Information
Official Title		Novel Imaging Modalities For Plexiform Neurofibromas
Trial Start Date		2002-04-12
Trial Completion Date		2010-12-31 (estimated)
Registered in ClinicalTrials.gov		NCT00060008
Date Submitted to PDQ		2003-03-13
Information Last Verified		2009-06-28

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