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Study of [F 18]HX4 Positron Emission Tomography (PET) as a Tool to Detect Hypoxia in Tumors (HX4-200)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01075399
First Posted: February 25, 2010
Last Update Posted: August 30, 2013
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.
Information provided by (Responsible Party):
Siemens Molecular Imaging
Results First Submitted: February 14, 2013  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Conditions: Head and Neck Cancer
Lung Cancer
Liver Cancer
Rectal Cancer
Cervical Cancer
Intervention: Drug: [F 18]HX4

  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
A total of 50 patients were enrolled into the study. There were 42 of 50 patients received at least one dose of [F-18]HX4 and had safety data collected. There were 39 of 50 patients completed two pre-treatment [F-18]HX4 PET/CT scans and were included in analyses to assess reproducibility.

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
[F 18]HX4 [F 18]HX4 : Approximately forty (40) patients who have diagnosis confirmed by histopathological examination of tumor tissue from head/neck, lung, liver, rectal or cervical cancers and will receive chemotherapy, radiation therapy or chemoradiotherapy, will be imaged under PET/CT with [F 18]HX4

Participant Flow:   Overall Study
    [F 18]HX4
STARTED   50 [1] 
COMPLETED   42 [2] 
NOT COMPLETED   8 
[1] A total of 50 patients were enrolled into the study.
[2] 42 of 50 patients received at least one dose and 39 of 50 patients completed two pre-treatment scan



  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.
A total of 50 patients were enrolled. A total of 42 patients received at least one dose of [F-18]HX4. Thirty-nine (39) patients completed two pre-treatment [F-18]HX4 PET/CT scans. Thirty (30) patients had an evaluable tumor response assessment 3 (±1) months after treatment start

Reporting Groups
  Description
[F 18]HX4 [F 18]HX4 : Approximately forty (40) patients who have diagnosis confirmed by histopathological examination of tumor tissue from head/neck, lung, liver, rectal or cervical cancers and will receive chemotherapy, radiation therapy or chemoradiotherapy, will be imaged under PET/CT with [F 18]HX4

Baseline Measures
   [F 18]HX4 
Overall Participants Analyzed 
[Units: Participants]
 42 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   26 
>=65 years   16 
Age 
[Units: Years]
Mean (Standard Deviation)
 59.0  (9.35) 
Gender 
[Units: Participants]
 
Female   20 
Male   22 
Region of Enrollment 
[Units: Participants]
 
Korea, Republic of   10 
United States   32 


  Outcome Measures

1.  Primary:   Reproducibility of [F18]HX4 PET Imaging in Measuring Hypoxia in Tumors   [ Time Frame: Time between 1st and 2nd scan was 1 to 6 days ]


  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:  
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:  
Name/Title: Edward M. Aten, MD, President
Organization: Certus International, Inc.
phone: 603.627.1212
e-mail: eaten@certusintl.com



Responsible Party: Siemens Molecular Imaging
ClinicalTrials.gov Identifier: NCT01075399     History of Changes
Other Study ID Numbers: HX4-200
First Submitted: February 23, 2010
First Posted: February 25, 2010
Results First Submitted: February 14, 2013
Results First Posted: August 30, 2013
Last Update Posted: August 30, 2013