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Trial record 47 of 49 for:    Peptide Receptor | Neuroendocrine Tumors

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

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ClinicalTrials.gov Identifier: NCT00565721
Recruitment Status : Completed
First Posted : November 30, 2007
Results First Posted : August 8, 2014
Last Update Posted : August 18, 2014
Sponsor:
Information provided by (Responsible Party):
GE Healthcare

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions High-grade Glioma
Lung Cancer
Head & Neck Cancer
Sarcoma
Melanoma
Intervention Drug: Fluciclatide Injection - (AH111585 (F18))
Enrollment 33
Recruitment Details A total of 33 subjects enrolled in this study. 16 subjects completed the study and 17 subjects did not.
Pre-assignment Details 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.
Arm/Group Title Fluciclatide Injection
Hide Arm/Group Description The patient would receive an injection of Fluciclatide (GE-135) (F18) at 10mCi (370 megabecquerels (MBq)).
Period Title: Overall Study
Started 33
Completed 16
Not Completed 17
Reason Not Completed
Screen Failure             2
Lost to Follow-up             6
Technical Problems             1
Physician Decision             2
Other reasons             6
Arm/Group Title Safety With Fluciclatide Injection
Hide Arm/Group Description The patient would receive an injection of Fluciclatide (GE-135) (F18) at 10mCi (370 megabecquerels (MBq)).
Overall Number of Baseline Participants 25
Hide Baseline Analysis Population Description
33 subjects enrolled/ started the study. 25 subjects were used in this study analysis.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 25 participants
50.4  (10.09)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
<=18 years
0
   0.0%
Between 18 and 65 years
25
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 25 participants
Female
16
  64.0%
Male
9
  36.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 25 participants
United States 24
United Kingdom 1
1.Primary Outcome
Title 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)
Hide Description

Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively. 0.22 and 0.24 equals a weak positive correlation and 0.16 and 0.18 equals a negligible correlation.

Three (3) of the 22 subjects did not have any αvβ3 integrin results. Ki-inp-Patlak is a graphical analysis technique based on the compartment model that uses linear regression to identify and analyze pharmacokinetics of tracers involving irreversible uptake.

Time Frame Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.
Hide Outcome Measure Data
Hide Analysis Population Description
This Outcome Measure was assessed among the Full Analysis Set (FAS), 3 of the 22 Subjects did not have any αvβ3 integrin results.
Arm/Group Title Correlation Between Ki_inp-Patlak and αvβ3 Optical Density
Hide Arm/Group Description:
Correlation between Imaging parameters. The selected imaging parameters that reflected (18F) Fluciclatide tracer uptake and retention.
Overall Number of Participants Analyzed 19
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Correlation coefficient
0.22
(-0.26 to 0.61)
2.Primary Outcome
Title 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)
Hide Description

Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively.

The Logan plot is the counterpart of the Patlak plot for reversible radiotracers.

Time Frame Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.
Hide Outcome Measure Data
Hide Analysis Population Description
This Outcome Measure was assessed among the Full Analysis Set (FAS), 3 of the 22 Subjects did not have any αvβ3 integrin results.
Arm/Group Title Correlation Between VT_inp-Logan and αvβ3 Optical Density
Hide Arm/Group Description:
Correlation between Imaging parameters. The selected imaging parameters that reflected (18F) Fluciclatide tracer uptake and retention.
Overall Number of Participants Analyzed 19
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Correlation coefficient
0.24
(-0.24 to 0.62)
3.Primary Outcome
Title 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)
Hide Description

Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively.

SUVw_55 is the standard uptake value at 55 minutes post-injection, normalized to weight.

Time Frame Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.
Hide Outcome Measure Data
Hide Analysis Population Description
This Outcome Measure was assessed among the Full Analysis Set (FAS), 3 of the 22 Subjects did not have any αvβ3 integrin results.
Arm/Group Title Correlation Between SUVw_55 and αvβ3 Optical Density
Hide Arm/Group Description:
Correlation between Imaging parameters. The selected imaging parameters that reflected (18F) Fluciclatide tracer uptake and retention.
Overall Number of Participants Analyzed 19
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Correlation coefficient
0.16
(-0.32 to 0.57)
4.Primary Outcome
Title 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)
Hide Description

Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.

Twelve (12) of the 22 subjects had renal cell carcinoma (RCC) the remaining subjects did not have RCC.

SUVR_55_blood is the standard uptake value ratio (tumor-to-blood) at 55 minutes post-injection.

Time Frame Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.
Hide Outcome Measure Data
Hide Analysis Population Description
This Outcome Measure was assessed among the Full Analysis Set (FAS), 3 of the 22 Subjects did not have any αvβ3 integrin results.
Arm/Group Title Correlation Between SUVR_55_blood and αvβ3 Optical Density
Hide Arm/Group Description:
Correlation between Imaging parameters. The selected imaging parameters that reflected (18F) Fluciclatide tracer uptake and retention.
Overall Number of Participants Analyzed 19
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Correlation coefficient
0.18
(-0.30 to 0.58)
5.Primary Outcome
Title 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)
Hide Description Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.
Time Frame Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.
Hide Outcome Measure Data
Hide Analysis Population Description
This Outcome Measure was assessed among the Renal Cell Carcinoma (RCC) subjects, 12 of the 22 Subjects had Renal Cell Carcinoma (RCC).
Arm/Group Title Correlation Between Ki_inp-Patlak and αvβ3 Optical Density
Hide Arm/Group Description:
Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention with Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors for the Renal Cell Carcinoma (RCC) subjects.
Overall Number of Participants Analyzed 12
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Correlation coefficient
0.49
(-0.14 to 0.82)
6.Primary Outcome
Title 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)
Hide Description Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.
Time Frame Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.
Hide Outcome Measure Data
Hide Analysis Population Description
This Outcome Measure was assessed among the Renal Cell Carcinoma (RCC) subjects, 12 of the 22 Subjects had Renal Cell Carcinoma (RCC).
Arm/Group Title Correlation Between VT_inp-Logan and αvβ3 Optical Density
Hide Arm/Group Description:
Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention with Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors for the Renal Cell Carcinoma (RCC) subjects.
Overall Number of Participants Analyzed 12
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Correlation coefficient
0.56
(-0.05 to 0.85)
7.Primary Outcome
Title 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)
Hide Description Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.
Time Frame Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.
Hide Outcome Measure Data
Hide Analysis Population Description
This Outcome Measure was assessed among the Renal Cell Carcinoma (RCC) subjects, 12 of the 22 Subjects had Renal Cell Carcinoma (RCC).
Arm/Group Title Correlation Between SUVw_55 and αvβ3 Optical Density
Hide Arm/Group Description:
Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention with Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors for the Renal Cell Carcinoma (RCC) subjects.
Overall Number of Participants Analyzed 12
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Correlation coefficient
0.49
(-0.13 to 0.83)
8.Primary Outcome
Title 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)
Hide Description Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.
Time Frame Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.
Hide Outcome Measure Data
Hide Analysis Population Description
This Outcome Measure was assessed among the Renal Cell Carcinoma (RCC) subjects, 12 of the 22 Subjects had Renal Cell Carcinoma (RCC).
Arm/Group Title Correlation Between SUVR_55_blood and αvβ3 Optical Density
Hide Arm/Group Description:
Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention with Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors for the Renal Cell Carcinoma (RCC) subjects.
Overall Number of Participants Analyzed 12
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Correlation coefficient
0.44
(-0.20 to 0.80)
9.Secondary Outcome
Title 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)
Hide Description

Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively. 0.60 to 0.44 equals a moderately positive correlation and 0.33 to 0.37 equals a weak positive correlation.

Two (2) of the 22 subjects did not have any αvβ5 integrin results.

Time Frame Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.
Hide Outcome Measure Data
Hide Analysis Population Description
This Outcome Measure was assessed among the Full Analysis Set (FAS), 2 of the 22 Subjects did not have any αvβ5 integrin results.
Arm/Group Title Correlation Between Ki_inp-Patlak αvβ5 Optical Density
Hide Arm/Group Description:
The patient would receive an injection of Fluciclatide (GE-135) (F18) at 10mCi (370 megabecquerels (MBq)). Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention with Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors for the Full Analysis Set (FAS) subjects.
Overall Number of Participants Analyzed 20
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Correlation coefficient
0.60
(0.20 to 0.82)
10.Secondary Outcome
Title 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)
Hide Description Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively.
Time Frame Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.
Hide Outcome Measure Data
Hide Analysis Population Description
This Outcome Measure was assessed among the Full Analysis Set (FAS), 2 of the 22 Subjects did not have any αvβ5 integrin results.
Arm/Group Title Correlation Between VT_inp-Logan and αvβ5 Optical Density
Hide Arm/Group Description:
The patient would receive an injection of Fluciclatide (GE-135) (F18) at 10mCi (370 megabecquerels (MBq)). Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention with Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors for the Renal Cell Carcinoma (RCC) subjects.
Overall Number of Participants Analyzed 20
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Correlation coefficient
0.44
(-0.01 to 0.73)
11.Secondary Outcome
Title 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)
Hide Description Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively.
Time Frame Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.
Hide Outcome Measure Data
Hide Analysis Population Description
This Outcome Measure was assessed among the Full Analysis Set (FAS), 2 of the 22 Subjects did not have any αvβ5 integrin results.
Arm/Group Title Correlation Between SUVw_55 and αvβ5 Optical Density
Hide Arm/Group Description:
Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively.
Overall Number of Participants Analyzed 20
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Correlation coefficient
0.33
(-0.14 to 0.67)
12.Secondary Outcome
Title 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)
Hide Description Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively.
Time Frame Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.
Hide Outcome Measure Data
Hide Analysis Population Description
This Outcome Measure was assessed among the Full Analysis Set (FAS), 2 of the 22 Subjects did not have any αvβ5 integrin results.
Arm/Group Title Correlation Between SUVR_55_blood and αvβ5 Optical Density
Hide Arm/Group Description:
Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively.
Overall Number of Participants Analyzed 20
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Correlation coefficient
0.37
(-0.10 to 0.69)
13.Secondary Outcome
Title 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)
Hide Description Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.
Time Frame Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.
Hide Outcome Measure Data
Hide Analysis Population Description
This Outcome Measure was assessed among the Renal Cell Carcinoma (RCC) subjects, 12 of the 22 Subjects had Renal Cell Carcinoma (RCC).
Arm/Group Title Correlation Between Ki_inp-Patlak and αvβ5 Optical Density
Hide Arm/Group Description:
Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.
Overall Number of Participants Analyzed 12
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Correlation coefficient
0.90
(0.67 to 0.97)
14.Secondary Outcome
Title 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)
Hide Description Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.
Time Frame Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.
Hide Outcome Measure Data
Hide Analysis Population Description
This Outcome Measure was assessed among the Renal Cell Carcinoma (RCC) subjects, 12 of the 22 Subjects had Renal Cell Carcinoma (RCC).
Arm/Group Title Correlation Between VT_inp-Logan and αvβ5 Optical Density
Hide Arm/Group Description:
Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.
Overall Number of Participants Analyzed 12
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Correlation coefficient
0.78
(0.34 to 0.93)
15.Secondary Outcome
Title 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)
Hide Description Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.
Time Frame Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.
Hide Outcome Measure Data
Hide Analysis Population Description
This Outcome Measure was assessed among the Renal Cell Carcinoma (RCC) subjects, 12 of the 22 Subjects had Renal Cell Carcinoma (RCC).
Arm/Group Title Correlation Between SUVw_55 and αvβ5 Optical Density
Hide Arm/Group Description:
Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.
Overall Number of Participants Analyzed 12
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Correlation coefficient
0.57
(-0.03 to 0.85)
16.Secondary Outcome
Title 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)
Hide Description Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.
Time Frame Tissue sample acquisition within 2 weeks of Fluciclatide PET scan.
Hide Outcome Measure Data
Hide Analysis Population Description
This Outcome Measure was assessed among the Renal Cell Carcinoma (RCC) subjects, 12 of the 22 Subjects had Renal Cell Carcinoma (RCC).
Arm/Group Title Correlation Between SUVR_55_blood and αvβ5 Optical Density
Hide Arm/Group Description:
Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.
Overall Number of Participants Analyzed 12
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Correlation coefficient
0.74
(0.27 to 0.92)
Time Frame Up to 6 weeks post administration of Fluciclatide (GE-135) (18F) Injection at 10 mCi [370 megabecquerels (MBq)].
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Fluciclatide Injection
Hide Arm/Group Description The patient would receive an injection of Fluciclatide (GE-135) (F18) at 10mCi (370 megabecquerels (MBq)).
All-Cause Mortality
Fluciclatide Injection
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Fluciclatide Injection
Affected / at Risk (%) # Events
Total   5/25 (20.00%)    
Blood and lymphatic system disorders   
Anemia  1  1/25 (4.00%)  1
Idiopathic Thrombocytopenic Purpura (ITP)  1  1/25 (4.00%)  1
Injury, poisoning and procedural complications   
Renal Injury  1  1/25 (4.00%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Glioblastoma Multiforme (GBM)  1  1/25 (4.00%)  1
Respiratory, thoracic and mediastinal disorders   
Pneumothorax  1  1/25 (4.00%)  1
Skin and subcutaneous tissue disorders   
Subcutaneous Emphysema  1  1/25 (4.00%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Fluciclatide Injection
Affected / at Risk (%) # Events
Total   13/25 (52.00%)    
Gastrointestinal disorders   
Gastrointestinal Disorders  1 [1]  3/25 (12.00%)  3
General disorders   
General disorders and administration site conditions  1 [1]  5/25 (20.00%)  6
Infections and infestations   
Infections and Infestations  1 [1]  3/25 (12.00%)  3
Investigations   
Investigations  1 [1]  3/25 (12.00%)  4
Respiratory, thoracic and mediastinal disorders   
Respiratory  1 [1]  2/25 (8.00%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (12.0)
[1]
AEs were described by system organ class.
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
Layout table for Results Point of Contact information
Name/Title: Paul Gordon, PhD
Organization: GE Healthcare
Phone: 011-47-2318-5822
EMail: paul.gordon@ge.com
Layout table for additonal information
Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT00565721     History of Changes
Obsolete Identifiers: NCT00923767
Other Study ID Numbers: GE-135-003
First Submitted: November 28, 2007
First Posted: November 30, 2007
Results First Submitted: June 3, 2014
Results First Posted: August 8, 2014
Last Update Posted: August 18, 2014