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F-18 Fluorothymidine PET Imaging for Early Evaluation of Response to Therapy in Head & Neck Cancer Patients

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00721799
First Posted: July 24, 2008
Last Update Posted: October 3, 2017
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.
Collaborators:
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Yusuf Menda, University of Iowa
Results First Submitted: March 29, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions: Mouth Neoplasms
Oropharyngeal Neoplasms
Laryngeal Neoplasms
Head and Neck Neoplasms
Intervention: Drug: 18F-Fluorothymidine PET scan

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
FLT PET

Subjects who receive F-18 Fluorothymidine [FLT]PET imaging prior to treatment.

F-18 Fluorothymidine: FLT PET scan [0.04 to 0.08 mCi/kg (maximum of 5 mCi +/- 10%)]


Participant Flow:   Overall Study
    FLT PET
STARTED   33 
Recieved FLT PET Scan 1   26 
Received FLT PET Scan #2   25 
COMPLETED   25 
NOT COMPLETED   8 
Withdrawal by Subject                7 
withdraw by subject after scan 1                1 



  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.
No text entered.

Reporting Groups
  Description
FLT PET

Subjects who receive F-18 Fluorothymidine [FLT]PET imaging prior to treatment.

F-18 Fluorothymidine: FLT PET scan [0.04 to 0.08 mCi/kg (maximum of 5 mCi +/- 10%)]


Baseline Measures
   FLT PET 
Overall Participants Analyzed 
[Units: Participants]
 26 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      21  80.8% 
>=65 years      5  19.2% 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.8  (10.0) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      2   7.7% 
Male      24  92.3% 
Ethnicity (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Hispanic or Latino      0   0.0% 
Not Hispanic or Latino      19  73.1% 
Unknown or Not Reported      7  26.9% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      0   0.0% 
White      23  88.5% 
More than one race      0   0.0% 
Unknown or Not Reported      3  11.5% 
Region of Enrollment 
[Units: Participants]
 
United States   26 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Efficacy of Mean Pre-therapy FLT Uptake (SUVmean) in Predicting Progression Free Survival (PFS)   [ Time Frame: 36 months ]

2.  Primary:   Efficacy of Maximum Pre-therapy FLT Uptake (SUVmax) in Predicting Progression Free Survival (PFS)   [ Time Frame: 36 months ]

3.  Primary:   Efficacy of Pre-therapy Metabolic Tumor Volume in Predicting Progression Free Survival (PFS)   [ Time Frame: 36 months ]

4.  Primary:   Efficacy of FLT Flux (K-FLT) Pre-therapy in Predicting Progression Free Survival (PFS)   [ Time Frame: 36 months ]

5.  Primary:   Efficacy of the Patlak Influx Rate Constant for FLT (K-Patlak) Pre-therapy in Predicting Progression Free Survival (PFS)   [ Time Frame: 36 months ]

6.  Primary:   Efficacy of Pretherapy Total Lesion Proliferation in Predicting Progression Free Survival (PFS)   [ Time Frame: 36 months ]

7.  Primary:   Efficacy of Mean Mid-therapy FLT Uptake (SUVmean) in Predicting Progression Free Survival (PFS)   [ Time Frame: 36 months ]

8.  Primary:   Efficacy of Maximum Mid-therapy FLT Uptake (SUVmax) in Predicting Progression Free Survival (PFS)   [ Time Frame: 36 months ]

9.  Primary:   Efficacy of FLT Flux (K-FLT) Mid-therapy in Predicting Progression Free Survival (PFS)   [ Time Frame: 36 months ]

10.  Primary:   Efficacy of the Patlak Influx Rate Constant for FLT (K-Patlak) Mid-therapy in Predicting Progression Free Survival (PFS)   [ Time Frame: 36 months ]

11.  Primary:   Efficacy of Mid-therapy Total Lesion Proliferation in Predicting Progression Free Survival (PFS)   [ Time Frame: 36 months ]

12.  Primary:   Efficacy of Percent Change in Mean FLT Uptake (SUVmean) Between Scan 1 & 2 in Predicting Progression Free Survival (PFS)   [ Time Frame: 36 months ]

13.  Primary:   Efficacy of Percent Change in Maximum FLT Uptake (SUVmax) Between Scans 1 & 2 in Predicting Progression Free Survival (PFS)   [ Time Frame: 36 months ]

14.  Primary:   Efficacy of Percent Change in FLT Flux (K-FLT) Between Scans 1 & 2 in Predicting Progression Free Survival (PFS)   [ Time Frame: 36 months ]

15.  Primary:   Efficacy of Percent Change the Patlak Influx Rate Constant for FLT (K-Patlak) Between Scans 1 & 2 in Predicting Progression Free Survival (PFS)   [ Time Frame: 36 months ]

16.  Primary:   Efficacy of Percent Change in the Total Lesion Proliferation Between Scans 1 & 2 in Predicting Progression Free Survival (PFS)   [ Time Frame: 36 months ]

17.  Primary:   Efficacy of Mean Pre-therapy FLT Uptake (SUVmean) in Predicting Overall Survival (OS)   [ Time Frame: 36 months ]

18.  Primary:   Efficacy of Maximum Pre-therapy FLT Uptake (SUVmax) in Predicting Overall Survival (OS)   [ Time Frame: 36 months ]

19.  Primary:   Efficacy of Pre-therapy Metabolic Tumor Volume in Predicting Overall Survival (OS)   [ Time Frame: 36 months ]

20.  Primary:   Efficacy of FLT Flux (K-FLT) Pre-therapy in Predicting Overall Survival (OS)   [ Time Frame: 36 months ]

21.  Primary:   Efficacy of the Patlak Influx Rate Constant for FLT (K-Patlak) Pre-therapy in Predicting Overall Survival (OS)   [ Time Frame: 36 months ]

22.  Primary:   Efficacy of Pretherapy Total Lesion Proliferation in Predicting Overall Survival (OS)   [ Time Frame: 36 months ]

23.  Primary:   Efficacy of Mean Mid-therapy FLT Uptake (SUVmean) in Predicting Overall Survival (OS)   [ Time Frame: 36 months ]

24.  Primary:   Efficacy of Maximum Mid-therapy FLT Uptake (SUVmax) in Predicting Overall Survival (OS)   [ Time Frame: 36 months ]

25.  Primary:   Efficacy of FLT Flux (K-FLT) Mid-therapy in Predicting Overall Survival (OS).   [ Time Frame: 36 months ]

26.  Primary:   Efficacy of the Patlak Influx Rate Constant for FLT (K-Patlak) Mid-therapy in Predicting Overall Survival (OS)   [ Time Frame: 36 months ]

27.  Primary:   Efficacy of Mid-therapy Total Lesion Proliferation in Predicting Overall Survival (OS)   [ Time Frame: 36 months ]

28.  Primary:   Efficacy of Percent Change in Mean FLT Uptake (SUVmean) in Predicting Overall Survival (OS)   [ Time Frame: 36 months ]

29.  Primary:   Efficacy of Percent Change in Maximum FLT Uptake (SUVmax) in Predicting Overall Survival (OS)   [ Time Frame: 36 months ]

30.  Primary:   Efficacy of Percent Change in FLT Flux (K-FLT) in Predicting Overall Survival (OS)   [ Time Frame: 36 months ]

31.  Primary:   Efficacy of Percent Change the Patlak Influx Rate Constant for FLT (K-Patlak) in Predicting Overall Survival (OS)   [ Time Frame: 36 months ]

32.  Primary:   Efficacy of Percent Change in the Total Lesion Proliferation in Predicting Overall Survival (OS)   [ Time Frame: 36 months ]


  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
  • HPV (human papilloma virus) status of tumors not available.
  • Therapy heterogeneity in the therapy; radiotherapy fairly consistent but chemotherapy regimens varied.
  • Small sample size is limiting.


  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: Yusuf Menda, MD
Organization: The University of Iowa Department of Radiology
phone: 319-356-3214
e-mail: yusuf-menda@uiowa.edu


Publications of Results:

Responsible Party: Yusuf Menda, University of Iowa
ClinicalTrials.gov Identifier: NCT00721799     History of Changes
Other Study ID Numbers: 200801758
1R21CA130281 ( U.S. NIH Grant/Contract )
First Submitted: June 10, 2008
First Posted: July 24, 2008
Results First Submitted: March 29, 2017
Results First Posted: October 3, 2017
Last Update Posted: October 3, 2017