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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00060008 |
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Date of registration:
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06/05/2003 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Fludeoxyglucose F 18 Positron Emission Tomography and Magnetic Resonance Perfusion Imaging in Patients With Neurofibromatosis 1 and Plexiform Neurofibroma
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Scientific title:
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Novel Imaging Modalities For Plexiform Neurofibromas |
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Date of first enrolment:
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April 2002 |
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Target sample size:
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18 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT00060008 |
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Study type:
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Interventional |
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Study design:
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Michael Fisher, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Children's Hospital of Philadelphia |
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Key inclusion & exclusion 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)
Age minimum:
N/A
Age maximum:
25 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Precancerous Condition
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Neurofibromatosis Type 1
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Intervention(s)
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Radiation: fludeoxyglucose F 18
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Radiation: gadopentetate dimeglumine
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Primary Outcome(s)
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Tumor Progression as Measured by Tumor Area and Volume at 1 Year.
[Time Frame: One year]
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Secondary ID(s)
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CDR0000299006
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2001-8-2543
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CHP-724
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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