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

Primary Purpose

Neurofibromatosis Type 1, Precancerous Condition

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
fludeoxyglucose F 18
gadopentetate dimeglumine
Sponsored by
Children's Hospital of Philadelphia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Neurofibromatosis Type 1 focused on measuring neurofibromatosis type 1, plexiform neurofibroma

Eligibility Criteria

undefined - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Abramson Cancer Center of the University of Pennsylvania
  • Children's Hospital of Philadelphia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

18FDG-PET scan and MR perfusion

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
May 6, 2003
Last Updated
April 3, 2014
Sponsor
Children's Hospital of Philadelphia
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1. Study Identification

Unique Protocol Identification Number
NCT00060008
Brief Title
Fludeoxyglucose F 18 Positron Emission Tomography and Magnetic Resonance Perfusion Imaging in Patients With Neurofibromatosis 1 and Plexiform Neurofibroma
Official Title
Novel Imaging Modalities For Plexiform Neurofibromas
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Terminated
Why Stopped
Study was closed early due to poor accrual.
Study Start Date
April 2002 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurofibromatosis Type 1, Precancerous Condition
Keywords
neurofibromatosis type 1, plexiform neurofibroma

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
18FDG-PET scan and MR perfusion
Arm Type
Experimental
Arm Description
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.
Intervention Type
Radiation
Intervention Name(s)
fludeoxyglucose F 18
Intervention Type
Radiation
Intervention Name(s)
gadopentetate dimeglumine
Primary Outcome Measure Information:
Title
Tumor Progression as Measured by Tumor Area and Volume at 1 Year.
Description
We correlated SUVmax and change in tumor volume over the subsequent year
Time Frame
One year

10. Eligibility

Sex
All
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Fisher, MD
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Study Chair
Facility Information:
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4283
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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