Fludeoxyglucose F 18 Positron Emission Tomography and Magnetic Resonance Perfusion Imaging in Patients With Neurofibromatosis 1 and Plexiform Neurofibroma

NCT00060008 | Terminated Results

• 3 other identifiers: 2001-8-2543CHP-724CDR0000299006
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Neurofibromatosis Type 1; Precancerous Condition

Keywords

neurofibromatosis type 1; plexiform neurofibroma

Outcome Measures

Primary Outcomes (1)

• Tumor Progression as Measured by Tumor Area and Volume at 1 Year.

  We correlated SUVmax and change in tumor volume over the subsequent year

  One year

Study Arms (1)

18FDG-PET scan and MR perfusion

EXPERIMENTAL

Subjects will undergo MRI for quantitative (2D and 3D) evaluation of plexiform neurofibroma size, MR perfusion scan, and fludeoxyglucose (18FDG) PET scan at the time of study entry. Subjects who are treated for plexiform neurofibroma will undergo another 18FDG PET scan after one year of study entry.

Radiation: fludeoxyglucose F 18; Radiation: gadopentetate dimeglumine

Interventions

fludeoxyglucose F 18 RADIATION

18FDG-PET scan and MR perfusion

gadopentetate dimeglumine RADIATION

18FDG-PET scan and MR perfusion

Eligibility Criteria

• Age: Up to 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead

Study Sites (2)

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Neurofibromatosis 1; Precancerous Conditions; Neurofibroma, Plexiform

Interventions

Fluorodeoxyglucose F18; Gadolinium DTPA

Condition Hierarchy (Ancestors)

Neurofibromatoses; Neurofibroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplastic Syndromes, Hereditary; Neurocutaneous Syndromes; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Peripheral Nervous System Neoplasms; Nervous System Neoplasms

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates; Pentetic Acid; Polyamines; Amines; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Coordination Complexes

Limitations and Caveats

The sample size was modest. It is possible that with increased sample size, if the correlation estimate holds, it will become statistically significant.

Results Point of Contact

• Title: Dr. Michael Fisher
• Organization: Children's Hospital of Philadelphia

fisherm@email.chop.edu

215 590 2800

Study Officials

• Michael Fisher, MD

  Children's Hospital of Philadelphia

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2003
• First Posted: May 7, 2003
• Study Start: April 1, 2002
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: April 4, 2014
• Results First Posted: April 4, 2014

Record last verified: 2014-04

Locations

US (2)