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

Novel Imaging Modalities For Plexiform Neurofibromas

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00060008
Enrollment
18
Registered
2003-05-07
Start date
2002-04-30
Completion date
2011-05-31
Last updated
2014-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neurofibromatosis Type 1, Precancerous Condition

Keywords

neurofibromatosis type 1, plexiform neurofibroma

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.

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.

Interventions

RADIATIONfludeoxyglucose F 18

Sponsors

Children's Hospital of Philadelphia
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 25 Years
Healthy volunteers
No

Inclusion 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)

Design outcomes

Primary

MeasureTime frameDescription
Tumor Progression as Measured by Tumor Area and Volume at 1 Year.One yearWe correlated SUVmax and change in tumor volume over the subsequent year

Countries

United States

Participant flow

Participants by arm

ArmCount
18FDG-PET Scan and MR Perfusion
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. fludeoxyglucose F 18 gadopentetate dimeglumine
18
Total18

Baseline characteristics

Characteristic18FDG-PET Scan and MR Perfusion
Age, Customized14.4 years
Sex: Female, Male
Female
9 Participants
Sex: Female, Male
Male
9 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 0
serious
Total, serious adverse events
0 / 0

Outcome results

Primary

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

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

Time frame: One year

ArmMeasureValue (MEDIAN)
SUVmax < 2Tumor Progression as Measured by Tumor Area and Volume at 1 Year.4 percentage of change
SUVmax >2Tumor Progression as Measured by Tumor Area and Volume at 1 Year.27 percentage of change
p-value: 0.016Wilcoxon (Mann-Whitney)

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026