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

First Received on May 6, 2003. Last Updated on January 27, 2010 History of Changes

Sponsor:	Children's Hospital of Philadelphia
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00060008

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:

Genetics Home Reference related topics: neurofibromatosis type 1 neurofibromatosis type 2 Help Me Understand Genetics

MedlinePlus related topics: Cancer MRI Scans Neurofibromatosis Nuclear Scans

Drug Information available for: Fluorodeoxyglucose F18 Gadolinium DTPA

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)

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

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:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

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:

Disease
Neurofibroma
Neurofibromatosis 1
Osteitis Fibrosa Cystica
Precancerous Conditions
Neurofibromatoses
Neurofibroma, Plexiform
Pathologic Processes
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 February 13, 2012