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

NCT ID: NCT00060008

Last Updated: 2014-04-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-04-30
• Study Completion Date: 2011-05-31

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.

Conditions

Neurofibromatosis Type 1; Precancerous Condition

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

fludeoxyglucose F 18

Intervention Type: RADIATION

gadopentetate dimeglumine

Intervention Type: RADIATION

Interventions

fludeoxyglucose F 18

Intervention Type: RADIATION

gadopentetate dimeglumine

Intervention Type: RADIATION

Eligibility Criteria

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)

• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital of Philadelphia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Fisher, MD

Role: STUDY_CHAIR

Children's Hospital of Philadelphia

Locations

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

CHP-724

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000299006

Identifier Type: -

Identifier Source: secondary_id

2001-8-2543

Identifier Type: -

Identifier Source: org_study_id