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Trial record 3 of 62 for:    Excel Diagnostics

A Multi - Center Study Of PET Imaging With [F-18] FLT & [F-18] FDG in Cancer Patients for Treatment Evaluation (FLT101)

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ClinicalTrials.gov Identifier: NCT00847509
Recruitment Status : Completed
First Posted : February 19, 2009
Results First Posted : September 27, 2013
Last Update Posted : September 27, 2013
Sponsor:
Information provided by (Responsible Party):
Siemens Molecular Imaging

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Lung Cancer
Head and Neck Cancer
Intervention Drug: [F-18]FLT
Enrollment 49
Recruitment Details A total of 49 patients were enrolled and 38 patients received investiational product.
Pre-assignment Details  
Arm/Group Title [F-18]FLT PET Scan
Hide Arm/Group Description Open label, nonrandomized, uncontrolled, single group assignment, multi-center clinical trial to evaluate [F-18] FLT as a PET imaging tool in cancer patients clinically scheduled for treatment with radiation or radiation - chemotherapy. Standard [F-18] FDG PET will be the active comparator.
Period Title: Overall Study
Started 49
Completed 38
Not Completed 11
Arm/Group Title [F-18]FLT Scan
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 49
Hide Baseline Analysis Population Description
A total of 49 patients were enrolled and 38 patients received investiational product.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants
<=18 years
0
   0.0%
Between 18 and 65 years
27
  55.1%
>=65 years
22
  44.9%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 49 participants
64.67  (10.38)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 49 participants
Female
26
  53.1%
Male
23
  46.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 49 participants
49
1.Primary Outcome
Title [F-18]FLT PET Scan for Early Assessment of Tumor Response to Radiation or Chemoradiotherapy Compared to [F-18] FDG PET Scan
Hide Description The sponsor decided not to further develop [F-18]FLT. Therefore, no further analysis was performed.
Time Frame 3-5 weeks after the start of radiation or chemo radio therapy
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title [F-18]FLT PET Scan
Hide Arm/Group Description:
Open label, nonrandomized, uncontrolled, single group assignment, multi-center clinical trial to evaluate [F-18] FLT as a PET imaging tool in cancer patients clinically scheduled for treatment with radiation or radiation - chemotherapy. Standard [F-18] FDG PET will be the active comparator.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 48 patients received investigational product at Visit 2 and 41 patients received investigational product at Visit 3
Adverse Event Reporting Description 48 patients received any amount of investigational prduct. One patient experienced AE prior to receiving any investigational product and was therefore not included in the naalysis of AE and concomitant medications.
 
Arm/Group Title [F-18]FLT PET Scan
Hide Arm/Group Description Open label, nonrandomized, uncontrolled, single group assignment, multi-center clinical trial to evaluate [F-18] FLT as a PET imaging tool in cancer patients clinically scheduled for treatment with radiation or radiation - chemotherapy. Standard [F-18] FDG PET will be the active comparator.
All-Cause Mortality
[F-18]FLT PET Scan
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
[F-18]FLT PET Scan
Affected / at Risk (%)
Total   0/38 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
[F-18]FLT PET Scan
Affected / at Risk (%)
Total   0/38 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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.
The restriction on the PI is that the sponsor can review results communication prior to public release and can embargo communications regarding trial results.
Results Point of Contact
Name/Title: Edward M. Aten, M.D.
Organization: Certus International, Inc.
Phone: 603.627.1212
Responsible Party: Siemens Molecular Imaging
ClinicalTrials.gov Identifier: NCT00847509     History of Changes
Other Study ID Numbers: FLT101
First Submitted: February 17, 2009
First Posted: February 19, 2009
Results First Submitted: July 26, 2013
Results First Posted: September 27, 2013
Last Update Posted: September 27, 2013