A Proof-of-concept Study to Assess the Ability of [18F]AH-111585 PET Imaging to Detect Tumours and Angiogenesis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT00565721
First received: November 28, 2007
Last updated: August 13, 2014
Last verified: August 2014
Results First Received: June 3, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Conditions: High-grade Glioma
Lung Cancer
Head & Neck Cancer
Sarcoma
Melanoma
Intervention: Drug: Fluciclatide Injection - (AH111585 (F18))

  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 33 subjects enrolled in this study. 16 subjects completed the study and 17 subjects did not.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
33 subjects enrolled,16 subjects completed and 17 did not complete. The reasons why 17 subjects that did not complete the study: 2 subjects failed screening, 6 subjects were lost to followup, 1 subject the procedure had technical problems, 2 subjects discontinued due to Physician decision, and 6 subjects had other reasons for not completing.

Reporting Groups
  Description
Fluciclatide Injection The patient would receive an injection of Fluciclatide (GE-135) (F18) at 10mCi (370 megabecquerels (MBq)).

Participant Flow:   Overall Study
    Fluciclatide Injection  
STARTED     33  
COMPLETED     16  
NOT COMPLETED     17  
Screen Failure                 2  
Lost to Follow-up                 6  
Technical Problems                 1  
Physician Decision                 2  
Other reasons                 6  



  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.
33 subjects enrolled/ started the study. 25 subjects were used in this study analysis.

Reporting Groups
  Description
Safety With Fluciclatide Injection The patient would receive an injection of Fluciclatide (GE-135) (F18) at 10mCi (370 megabecquerels (MBq)).

Baseline Measures
    Safety With Fluciclatide Injection  
Number of Participants  
[units: participants]
  25  
Age  
[units: years]
Mean ± Standard Deviation
  50.4  ± 10.09  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     25  
>=65 years     0  
Gender  
[units: participants]
 
Female     16  
Male     9  
Region of Enrollment  
[units: participants]
 
United States     24  
United Kingdom     1  



  Outcome Measures
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1.  Primary:   Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ3 (Beta-3 Integrin) Integrin Expression in Tumors. (Correlation Between Ki_inp-Patlak and αvβ3 Optical Density)   [ Time Frame: Tissue sample acquisition within 2 weeks of Fluciclatide PET scan. ]

2.  Primary:   Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors. (Correlation Between VT_inp-Logan and αvβ3 Optical Density)   [ Time Frame: Tissue sample acquisition within 2 weeks of Fluciclatide PET scan. ]

3.  Primary:   Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ3 (Beta-3 Integrin) Integrin Expression in Tumors. (Correlation Between SUVw_55 and αvβ3 Optical Density)   [ Time Frame: Tissue sample acquisition within 2 weeks of Fluciclatide PET scan. ]

4.  Primary:   Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ3 (Beta-3 Integrin) Integrin Expression in Tumors. (Correlation Between SUVR_55_blood and αvβ3 Optical Density)   [ Time Frame: Tissue sample acquisition within 2 weeks of Fluciclatide PET scan. ]

5.  Primary:   Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors. (Correlation Between Ki_inp-Patlak and αvβ3 Optical Density)   [ Time Frame: Tissue sample acquisition within 2 weeks of Fluciclatide PET scan. ]

6.  Primary:   Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors. (Correlation Between VT_inp-Logan and αvβ3 Optical Density)   [ Time Frame: Tissue sample acquisition within 2 weeks of Fluciclatide PET scan. ]

7.  Primary:   Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors. (Correlation Between SUVw_55 and αvβ3 Optical Density)   [ Time Frame: Tissue sample acquisition within 2 weeks of Fluciclatide PET scan. ]

8.  Primary:   Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors. (Correlation Between SUVR_55_blood and αvβ3 Optical Density)   [ Time Frame: Tissue sample acquisition within 2 weeks of Fluciclatide PET scan. ]

9.  Secondary:   Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between Ki_inp-Patlak αvβ5 Optical Density)   [ Time Frame: Tissue sample acquisition within 2 weeks of Fluciclatide PET scan. ]

10.  Secondary:   Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between VT_inp-Logan and αvβ5 Optical Density)   [ Time Frame: Tissue sample acquisition within 2 weeks of Fluciclatide PET scan. ]

11.  Secondary:   Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between SUVw_55 and αvβ5 Optical Density)   [ Time Frame: Tissue sample acquisition within 2 weeks of Fluciclatide PET scan. ]

12.  Secondary:   Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between SUVR_55_blood and αvβ5 Optical Density)   [ Time Frame: Tissue sample acquisition within 2 weeks of Fluciclatide PET scan. ]

13.  Secondary:   Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between Ki_inp-Patlak and αvβ5 Optical Density)   [ Time Frame: Tissue sample acquisition within 2 weeks of Fluciclatide PET scan. ]

14.  Secondary:   Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between VT_inp-Logan and αvβ5 Optical Density)   [ Time Frame: Tissue sample acquisition within 2 weeks of Fluciclatide PET scan. ]

15.  Secondary:   Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between SUVw_55 and αvβ5 Optical Density)   [ Time Frame: Tissue sample acquisition within 2 weeks of Fluciclatide PET scan. ]

16.  Secondary:   Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention With Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors. (Correlation Between SUVR_55_blood and αvβ5 Optical Density)   [ Time Frame: Tissue sample acquisition within 2 weeks of Fluciclatide PET 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
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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: Paul Gordon, PhD
Organization: GE Healthcare
phone: 011-47-2318-5822
e-mail: paul.gordon@ge.com


No publications provided


Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT00565721     History of Changes
Obsolete Identifiers: NCT00923767
Other Study ID Numbers: GE-135-003
Study First Received: November 28, 2007
Results First Received: June 3, 2014
Last Updated: August 13, 2014
Health Authority: United States: Food and Drug Administration