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Trial record 11 of 12 for:    gadoteridol

MRI Study With Ferumoxytol in Assessing Early Response in Patients With Glioblastoma Multiforme Receiving Temozolomide and Radiation Therapy

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ClinicalTrials.gov Identifier: NCT00660543
Recruitment Status : Completed
First Posted : April 17, 2008
Results First Posted : May 16, 2016
Last Update Posted : May 16, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Edward Neuwelt, OHSU Knight Cancer Institute

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Adult Brain Glioblastoma
Interventions Drug: Gadolinium
Drug: Ferumoxytol Non-Stoichiometric Magnetite
Other: Dynamic Contrast-Enhanced Magnetic Resonance Imaging
Other: Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging
Other: Diffusion Weighted Imaging
Other: MRI-Based Angiogram
Enrollment 14
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Gadoteridol + Ferumoxytol Contrast Agent
Hide Arm/Group Description Subjects all received gadolinium enhanced MR on day 1, ferumoxytol enhanced MR on day 2, and delayed MR imaging on day 3 - this 3 day sequence of imaging was repeated at four time points.
Period Title: Overall Study
Started 14
Completed 14
Not Completed 0
Arm/Group Title Gadoteridol + Ferumoxytol Contrast Agent
Hide Arm/Group Description Subjects all received gadolinium enhanced MR on day 1, ferumoxytol enhanced MR on day 2, and delayed MR imaging on day 3 - this 3 day sequence of imaging was repeated at four time points.
Overall Number of Baseline Participants 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
<=18 years
0
   0.0%
Between 18 and 65 years
9
  64.3%
>=65 years
5
  35.7%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 14 participants
60
(43 to 81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants
Female
5
  35.7%
Male
9
  64.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 14 participants
14
1.Primary Outcome
Title Mean Cerebral Blood Volume (CBV)
Hide Description Radiographical progression is determined based on RANO criteria.
Time Frame At radiographical progression (between 6 and 12 weeks post first dose of chemoradiation)
Hide Outcome Measure Data
Hide Analysis Population Description
All patients with treated GMB showed apparent tumor progression on conventional MR images.
Arm/Group Title Ferumoxytol Gadoteridol Gadoteridol Leakage Correction
Hide Arm/Group Description:
Patients receive gadolinium IV on day 1 and ferumoxytol non-stoichiometric magnetite IV on day 2 then undergo DSC MRI, and DCE MRI, DWI (day 1 only), and TOF MR angiography on days 1-3 at 4 time points: before radiation, 3 weeks after initiation of radiation plus temozolomide, at the end of radiation (6 weeks post first dose) and 6 weeks after radiation (12 weeks post first dose).
Patients receive gadoteridol IV on day 1 then undergo DSC MRI, and DCE MRI, DWI (day 1 only), and TOF MR angiography on days 1-3 at 4 time points: before radiation, 3 weeks after initiation of radiation plus temozolomide, at the end of radiation (6 weeks post first dose) and 6 weeks after radiation (12 weeks post first dose).
Patients receive gadoteridol IV on day 1 then undergo DSC MRI, and DCE MRI, DWI (day 1 only), and TOF MR angiography on days 1-3 at 4 time points: before radiation, 3 weeks after initiation of radiation plus temozolomide, at the end of radiation (6 weeks post first dose) and 6 weeks after radiation (12 weeks post first dose).
Overall Number of Participants Analyzed 14 14 14
Mean (Standard Deviation)
Unit of Measure: mL/g
2.5  (2.1) 1.38  (1.73) 2.36  (1.94)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Ferumoxytol, Gadoteridol
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .003
Comments [Not Specified]
Method t-test, 1 sided
Comments Differences between groups were assessed by using the Student paired t test and were graphed by using Bland-Altman plots.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Ferumoxytol, Gadoteridol Leakage Correction
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .008
Comments [Not Specified]
Method t-test, 1 sided
Comments Differences between groups were assessed by using the Student paired t test and were graphed by using Bland-Altman plots.
2.Primary Outcome
Title Tumor Progression on Conventional MR
Hide Description Tumor progression was assessed by RANO criteria (Wen, 2010).
Time Frame Anytime between baseline and 12 weeks post treatment initiation: average 6 weeks post treatment initiation.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tumor Progression on Conventional MR
Hide Arm/Group Description:
Tumor progression was assessed by RANO criteria (Wen, 2010).
Overall Number of Participants Analyzed 14
Measure Type: Number
Unit of Measure: participants
14
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ferumoxytol Gadoteridol Gadoteridol With Leakage Correction
Hide Arm/Group Description Subjects all received ferumoxytol enhanced MR on day 1, ferumoxytol enhanced MR on day 2, and delayed MR imaging on day 3 - this 3 day sequence of imaging was repeated at four time points Subjects all received gadolinium enhanced MR on day 1, ferumoxytol enhanced MR on day 2, and delayed MR imaging on day 3 - this 3 day sequence of imaging was repeated at four time points Subjects all received gadolinium enhanced MR on day 1, ferumoxytol enhanced MR on day 2, and delayed MR imaging on day 3 - this 3 day sequence of imaging was repeated at four time points
All-Cause Mortality
Ferumoxytol Gadoteridol Gadoteridol With Leakage Correction
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Ferumoxytol Gadoteridol Gadoteridol With Leakage Correction
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/14 (0.00%)      0/14 (0.00%)      0/14 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ferumoxytol Gadoteridol Gadoteridol With Leakage Correction
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/14 (7.14%)      0/14 (0.00%)      0/14 (0.00%)    
Gastrointestinal disorders       
Nausea   1/14 (7.14%)  1 0/14 (0.00%)  0 0/14 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Edward Neuwelt
Organization: Oregon Health and Science University
Phone: 503-494-5626
EMail: neuwelte@ohsu.edu
Layout table for additonal information
Responsible Party: Edward Neuwelt, OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT00660543     History of Changes
Other Study ID Numbers: IRB00002753
NCI-2015-00224 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
SOL-06062-LX
813
NCI-2015-00204
8097
2753 ( Other Identifier: OHSU Knight Cancer Institute )
P30CA069533 ( U.S. NIH Grant/Contract )
First Submitted: April 10, 2008
First Posted: April 17, 2008
Results First Submitted: February 12, 2016
Results First Posted: May 16, 2016
Last Update Posted: May 16, 2017