Fludeoxyglucose F 18 Positron Emission Tomography and Magnetic Resonance Perfusion Imaging in Patients With Neurofibromatosis 1 and Plexiform Neurofibroma
Information source: Children's Hospital of Philadelphia
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Neurofibromatosis Type 1; Precancerous Condition
Intervention: fludeoxyglucose F 18 (Radiation); gadopentetate dimeglumine (Radiation)
Phase: N/A
Status: Terminated
Sponsored by: Children's Hospital of Philadelphia Official(s) and/or principal investigator(s): Michael Fisher, MD, Study Chair, Affiliation: Children's Hospital of Philadelphia
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.
Clinical Details
Official title: Novel Imaging Modalities For Plexiform Neurofibromas
Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Primary outcome: Tumor Progression as Measured by Tumor Area and Volume at 1 Year.
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
Minimum age: N/A.
Maximum age: 25 Years.
Gender(s): Both.
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)
Locations and Contacts
Abramson Cancer Center of the University of Pennsylvania, Philadelphia, Pennsylvania 19104-4283, United States
Children's Hospital of Philadelphia, Philadelphia, Pennsylvania 19104, United States
Additional Information
Starting date: April 2002
Last updated: April 3, 2014
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