Clinical trial NCT00060008: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Neurofibromatosis Type 1
Precancerous Condition
Keywords: neurofibromatosis type 1
plexiform neurofibroma
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
First posted: 2003-05-07
Enrollment: 18
Sex: ALL
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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)

Primary outcomes:
measure: Tumor Progression as Measured by Tumor Area and Volume at 1 Year.
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Michael Fisher, MD
role: STUDY_CHAIR
References: