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GE-148-002: A Phase 2, Open-label, Single-Center Study to Assess GE-148 (18F) Injection PET Imaging to Detect Localized Prostate Cancer

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ClinicalTrials.gov Identifier: NCT01176513
Recruitment Status : Terminated (Lack of Subject enrollment)
First Posted : August 6, 2010
Results First Posted : November 21, 2013
Last Update Posted : February 14, 2014
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
GE Healthcare

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Prostate Cancer
Intervention Drug: GE-148 (18F)
Enrollment 25
Recruitment Details  
Pre-assignment Details 25 subjects were enrolled in this study and 3 subjects withdrew prior to dosing with this product. As a result, 22 subjects were used in the analysis for this study.
Arm/Group Title GE 148-002
Hide Arm/Group Description GE-148 (18F) : All subjects will receive an i.v. dose of GE-148 (18F) Injection at 10 mCi (370 MBq) to provide adequate image quality throughout the specified imaging period.
Period Title: Overall Study
Started 25
Completed 22
Not Completed 3
Reason Not Completed
Withdrew subjects prior to dosing             3
Arm/Group Title GE 148-002
Hide Arm/Group Description GE-148 (18F) : All subjects will receive an i.v. dose of GE-148 (18F) Injection at 10 mCi (370 MBq) to provide adequate image quality throughout the specified imaging period.
Overall Number of Baseline Participants 22
Hide Baseline Analysis Population Description
25 subjects were enrolled in the study and 3 subjects withdrew prior to dosing with the product. As a result, 22 subjects were used in the analysis.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
<=18 years
0
   0.0%
Between 18 and 65 years
15
  68.2%
>=65 years
7
  31.8%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants
61.0  (6.98)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Female
0
   0.0%
Male
22
 100.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants
22
1.Primary Outcome
Title To Assess the Magnitude of Uptake and Retention of GE-148 (18F) Injection in Malignant Prostate Tumors, Non-malignant Prostate Pathology, and Regions of Normal Prostate Tissue in Subjects With Prostate Cancer, Using PET/CT Imaging.
Hide Description Quantitative measurements of the level of uptake of GE-148 (18F) Injection into each tissue type (malignant prostate tumors, non-malignant prostate pathology, and regions of normal prostate) calculated as Standardized Uptake Values (SUVs), using histopathology as the standard of truth.
Time Frame After GE-148 (18F) Injection administration.
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analyses were not performed because GE Healthcare terminated the study early for administrative reasons.
Arm/Group Title GE 148-002
Hide Arm/Group Description:

GE-148 (18F) : All subjects will receive an i.v. dose of GE-148 (18F) Injection at 10 mCi (370 MBq) to provide adequate image quality throughout the specified imaging period.

Efficacy analyses were not performed because GE Healthcare terminated the study early for administrative reasons.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title To Compare the Ability of PET/CT Imaging With GE-148 (18F) Injection to Predict Prostate Malignancy and Distinguish it From Other Pathologies (Inflammation, Hyperplasia, Atrophy, Hemorrhage) With That of T2W MRI, DCE MRI, MR DWI, and MRSI Performed at 3T.
Hide Description Use of descriptive statistics to compare the ability of the PET/CT imaging and MRI to predict malignancy, based on histopathology as the standard of truth, on a subject basis and per lesion basis.
Time Frame After GE-148 (18F) Injection administration
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analyses were not performed because GE Healthcare terminated the study early for administrative reasons.
Arm/Group Title GE 148-002
Hide Arm/Group Description:

GE-148 (18F) : All subjects will receive an i.v. dose of GE-148 (18F) Injection at 10 mCi (370 MBq) to provide adequate image quality throughout the specified imaging period.

Efficacy analyses were not performed because GE Healthcare terminated the study early for administrative reasons.

Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title GE 148-002
Hide Arm/Group Description

GE-148 (18F) : All subjects will receive an i.v. dose of GE-148 (18F) Injection at 10 mCi (370 MBq) to provide adequate image quality throughout the specified imaging period.

Efficacy analyses were not performed because GE Healthcare terminated the study early for administrative reasons.

All-Cause Mortality
GE 148-002
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
GE 148-002
Affected / at Risk (%) # Events
Total   0/22 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
GE 148-002
Affected / at Risk (%) # Events
Total   2/22 (9.09%)    
Nervous system disorders   
Dysgeusia * 1  2/22 (9.09%)  2
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 14.1
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
Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01176513     History of Changes
Obsolete Identifiers: NCT01313091
Other Study ID Numbers: GE-148-002
10-C-0179
First Submitted: August 5, 2010
First Posted: August 6, 2010
Results First Submitted: September 20, 2013
Results First Posted: November 21, 2013
Last Update Posted: February 14, 2014