Novel Imaging Modalities For Plexiform Neurofibromas
N/A
25 Years
Both
Neurofibromatosis Type 1, Precancerous Condition
Trial Information
Novel Imaging Modalities For Plexiform Neurofibromas
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.
Inclusion 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)
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
Tumor progression as measured by tumor area and volume at 1 year
Safety Issue:
No
Principal Investigator
Michael Fisher, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Children's Hospital of Philadelphia
Authority:
Unspecified
Study ID:
CDR0000299006
NCT ID:
NCT00060008
Start Date:
April 2002
Completion Date:
Related Keywords:
- Neurofibromatosis Type 1
- Precancerous Condition
- neurofibromatosis type 1
- plexiform neurofibroma
- Neurofibroma
- Neurofibromatoses
- Neurofibromatosis 1
- Osteitis Fibrosa Cystica
- Precancerous Conditions
- Neurofibroma, Plexiform
Name | Location |
|---|---|
| Children's Hospital of Philadelphia | Philadelphia, Pennsylvania 19104 |
| Abramson Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania 19104-4283 |
