View Clinical Trial (Medical Research Study)
Novel Imaging Modalities For Plexiform Neurofibromas
| City: |
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Philadelphia |
| State: |
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Pennsylvania |
| Zip Code: |
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19104 |
| Conditions: |
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Neurofibromatosis Type 1 - Precancerous Condition |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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)
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| NCT ID: |
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NCT00060008 |
| Primary Contact: |
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Study Chair
Michael Fisher, MD
Children's Hospital of Philadelphia
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| Backup Contact: |
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N/A |
| Location Contact: |
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Philadelphia, Pennsylvania 19104
United States
Clinical Trials Office - Abramson Cancer Center of the Univers
Phone: 800-474-9892
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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