Fludeoxyglucose F 18 Positron Emission Tomography and Magnetic Resonance Perfusion Imaging in Patients With Neurofibromatosis 1 and Plexiform Neurofibroma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by National Cancer Institute (NCI).
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Children's Hospital of Philadelphia
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00060008
First received: May 6, 2003
Last updated: January 27, 2010
Last verified: June 2009
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Neurofibromatosis Type 1 Precancerous Condition |
Procedure: magnetic resonance imaging Procedure: positron emission tomography Procedure: radionuclide imaging Radiation: fludeoxyglucose F 18 Radiation: gadopentetate dimeglumine |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Novel Imaging Modalities For Plexiform Neurofibromas |
Resource links provided by NLM:
Drug Information available for:
Gadopentetate dimeglumine
Fludeoxyglucose F 18
Gadobenate Dimeglumine
U.S. FDA Resources
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Tumor progression as measured by tumor area and volume at 1 year [ Designated as safety issue: No ]
| Estimated Enrollment: | 48 |
| Study Start Date: | April 2002 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
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| Ages Eligible for Study: | up to 25 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00060008
Locations
| United States, Pennsylvania | |
| Abramson Cancer Center of the University of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104-4283 | |
| Contact: Clinical Trials Office - Abramson Cancer Center of the Univers 800-474-9892 | |
| Children's Hospital of Philadelphia | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Michael Fisher, MD 215-590-3129 | |
Sponsors and Collaborators
Children's Hospital of Philadelphia
Investigators
| Study Chair: | Michael Fisher, MD | Children's Hospital of Philadelphia |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00060008 History of Changes |
| Other Study ID Numbers: | CDR0000299006, CHP-724, CHP-IRB-2001-8-2543 |
| Study First Received: | May 6, 2003 |
| Last Updated: | January 27, 2010 |
| Health Authority: | Unspecified |
Keywords provided by National Cancer Institute (NCI):
|
neurofibromatosis type 1 plexiform neurofibroma |
Additional relevant MeSH terms:
|
Neurofibroma Neurofibromatosis 1 Osteitis Fibrosa Cystica Precancerous Conditions Neurofibromatoses Neurofibroma, Plexiform Nerve Sheath Neoplasms Neoplasms, Nerve Tissue Neoplasms by Histologic Type Neoplasms Peripheral Nervous System Neoplasms Nervous System Neoplasms |
Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Neoplastic Syndromes, Hereditary Neurocutaneous Syndromes Heredodegenerative Disorders, Nervous System Neurodegenerative Diseases Genetic Diseases, Inborn Bone Diseases, Endocrine Bone Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 23, 2013