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Trial record 57 of 95 for:    gadobenate dimeglumine

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00060008
Recruitment Status : Terminated (Study was closed early due to poor accrual.)
First Posted : May 7, 2003
Results First Posted : April 4, 2014
Last Update Posted : April 4, 2014
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Neurofibromatosis Type 1
Precancerous Condition
Interventions Radiation: fludeoxyglucose F 18
Radiation: gadopentetate dimeglumine
Enrollment 18
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 18FDG-PET Scan and MR Perfusion
Hide Arm/Group 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.

fludeoxyglucose F 18

gadopentetate dimeglumine

Period Title: Overall Study
Started 18
Completed 18
Not Completed 0
Arm/Group Title 18FDG-PET Scan and MR Perfusion
Hide Arm/Group 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.

fludeoxyglucose F 18

gadopentetate dimeglumine

Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 18 participants
14.4
(6 to 27)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
9
  50.0%
Male
9
  50.0%
1.Primary Outcome
Title Tumor Progression as Measured by Tumor Area and Volume at 1 Year.
Hide Description We correlated SUVmax and change in tumor volume over the subsequent year
Time Frame One year
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title SUVmax < 2 SUVmax >2
Hide Arm/Group Description:
Subjects underwent MRI for quantitative (3D) evaluation of plexiform neurofibroma size and fludeoxyglucose (18FDG) PET scan at the time of study entry.
Subjects underwent MRI for quantitative (3D) evaluation of plexiform neurofibroma size and fludeoxyglucose (18FDG) PET scan at the time of study entry.
Overall Number of Participants Analyzed 11 4
Overall Number of Units Analyzed
Type of Units Analyzed: Tumors
15 4
Median (Full Range)
Unit of Measure: percentage of change
4
(-0.6 to 63)
27
(16 to 32)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection SUVmax < 2, SUVmax >2
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description Adverse Events were not collected for this study.
 
Arm/Group Title 18FDG-PET Scan and MR Perfusion
Hide Arm/Group 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.

fludeoxyglucose F 18

gadopentetate dimeglumine

All-Cause Mortality
18FDG-PET Scan and MR Perfusion
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
18FDG-PET Scan and MR Perfusion
Affected / at Risk (%)
Total   0/0 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
18FDG-PET Scan and MR Perfusion
Affected / at Risk (%)
Total   0/0 
The sample size was modest. It is possible that with increased sample size, if the correlation estimate holds, it will become statistically significant.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Michael Fisher
Organization: Children's Hospital of Philadelphia
Phone: 215 590 2800
Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00060008     History of Changes
Other Study ID Numbers: 2001-8-2543
CHP-724 ( Other Identifier: Children's Hospital of Philadelphia )
CDR0000299006
First Submitted: May 6, 2003
First Posted: May 7, 2003
Results First Submitted: April 1, 2014
Results First Posted: April 4, 2014
Last Update Posted: April 4, 2014