FDG and FMISO PET Hypoxia Evaluation in Cervical Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00559377
First received: November 15, 2007
Last updated: June 3, 2015
Last verified: December 2013
Results First Received: October 29, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Conditions: Cervical Adenocarcinoma
Cervical Squamous Cell Carcinoma
Stage IB Cervical Cancer
Stage IIA Cervical Cancer
Stage IIB Cervical Cancer
Stage III Cervical Cancer
Stage IVA Cervical Cancer
Stage IVB Cervical Cancer
Interventions: Other: 18F-fluoromisonidazole
Radiation: fluorodeoxyglucose F 18
Procedure: positron emission tomography
Other: tissue oxygen measurement

  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
Diagnostic (^18F FMISO PET and ^18F FDG PET) Patients receive ^18F FMISO IV followed by PET scanning. Patients undergo a second ^18F FMISO PET scan 4-8 weeks later. Patients who have not had a prior ^18F FDG PET scan as part of their routine clinical management undergo ^18F FDG PET scanning at baseline.

Participant Flow:   Overall Study
    Diagnostic (^18F FMISO PET and ^18F FDG PET)  
STARTED     16  
COMPLETED     7  
NOT COMPLETED     9  
Withdrawal by Subject                 9  



  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
All Patients Patients receive ^18F FMISO IV followed by PET scanning. Patients undergo a second ^18F FMISO PET scan 4-8 weeks later.

Baseline Measures
    All Patients  
Number of Participants  
[units: participants]
  16  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     16  
>=65 years     0  
Gender  
[units: participants]
 
Female     16  
Male     0  
Region of Enrollment  
[units: participants]
 
United States     16  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Overall Survival (OS)   [ Time Frame: For up to 2 years ]

2.  Primary:   Disease-free Survival (DFS)   [ Time Frame: Up to 2 years ]

3.  Secondary:   Relationship Between Hypoxia-related IHC Biomarkers and Regional FMISO Uptake in Tumor   [ Time Frame: Up to 2 years ]

4.  Secondary:   Relationship Between Ki67 and Regional FMISO Uptake in Tumor   [ Time Frame: Up to 2 years ]

5.  Secondary:   Response to XRT Using RECIST   [ Time Frame: time to disease progression or 2 years following first FMISO scan ]


  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
Small number of subjects enrolled and events limit meaningful statistical analysis.


  More Information
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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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Joseph G Rajendran
Organization: UWMC Dept of Radiology
phone: 206-221-4421
e-mail: rajan@u.washington.edu


No publications provided


Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00559377     History of Changes
Other Study ID Numbers: NCI-2009-00257, NCI-2009-00257, UW IRB# 6143, 7958, N01CM37008
Study First Received: November 15, 2007
Results First Received: October 29, 2014
Last Updated: June 3, 2015
Health Authority: United States: Food and Drug Administration