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[F-18] Fluorothymidine (FLT) Imaging on Patients With Primary Brain Tumors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Utah
ClinicalTrials.gov Identifier:
NCT00707343
First received: June 26, 2008
Last updated: January 4, 2016
Last verified: January 2016
Results First Received: October 14, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Conditions: Cancer
Brain Tumors
Intervention: Radiation: FLT-PET Imaging

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
FLT-PET Imaging: [F-18] FLT

All participants enrolled.

FLT-PET Imaging: radiopharmaceutical 3'-deoxy-3'-[F-18]fluorothymidine, [F-18]FLT, a radiopharmaceutical that directly assess tumor proliferation using Positron Emission Tomography(PET) in differentiating tumor recurrence from radiation necrosis in a group of patients with glial neoplasms.


Participant Flow:   Overall Study
    FLT-PET Imaging: [F-18] FLT
STARTED   15 
COMPLETED   15 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
FLT-PET Imaging: [F-18] FLT

All participants enrolled.

FLT-PET Imaging: radiopharmaceutical 3'-deoxy-3'-[F-18]fluorothymidine, [F-18]FLT, a radiopharmaceutical that directly assess tumor proliferation using Positron Emission Tomography(PET) in differentiating tumor recurrence from radiation necrosis in a group of patients with glial neoplasms.


Baseline Measures
   FLT-PET Imaging: [F-18] FLT 
Overall Participants Analyzed 
[Units: Participants]
 15 
Age 
[Units: Years]
Median (Full Range)
 47 
 (22 to 75) 
Gender 
[Units: Participants]
 
Female   6 
Male   9 


  Outcome Measures

1.  Primary:   Area Under the Receiver Operating Curve (ROC AUC) Values for PET Imaging Techniques   [ Time Frame: 30 minutes for FDG imaging, 70 minutes for FLT imaging acquisition; 2-33 months for lesion outcome confirmation ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Mark Wade, Ph.D. - Compliance Officer
Organization: Huntsman Cancer Institute
phone: 801-213-5746
e-mail: mark.wade@hci.utah.edu



Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT00707343     History of Changes
Other Study ID Numbers: HCI20112
Study First Received: June 26, 2008
Results First Received: October 14, 2015
Last Updated: January 4, 2016
Health Authority: United States: Food and Drug Administration