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Gadoxetate Enhanced Imaging Study to Detect Prostate Cancer

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ClinicalTrials.gov Identifier: NCT01867424
Recruitment Status : Completed
First Posted : June 4, 2013
Results First Posted : March 20, 2018
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
Ismail B. Turkbey, National Cancer Institute (NCI)

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Prostate Cancer
Intervention Drug: Eovist
Enrollment 24
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Participants With Advanced Disease Participants With Localized Disease
Hide Arm/Group Description

Advanced disease: who have failed hormone therapy and who have sufficient tissue from a soft tissue or metastatic bone lesion (measuring 1.5cm in diameter at computed tomography (CT) or magnetic resonance imaging (MRI) scan) available for organic anion-transporting polypeptide 1B3 (OATP1B3) immunohistochemistry (IHC) or must have a soft tissue or metastatic bone lesion that can be biopsied and be willing to undergo percutaneous biopsy to obtain tissue for OATP1B3 expression.

Eovist: 0.1 ml/kg Eovist will be administered intravenous (IV) to each patient

Localized disease: must have image guided biopsy confirmed prostate cancer and sufficient tissue available for OATP1B3 IHC.

Eovist: 0.1 ml/kg Eovist will be administered intravenous (IV) to each patient

Period Title: Overall Study
Started 12 12
Completed 10 11
Not Completed 2 1
Reason Not Completed
Patient noncompliance             2             1
Arm/Group Title Participants With Advanced Disease Participants With Localized Disease Total
Hide Arm/Group Description

Advanced disease: who have failed hormone therapy and who have sufficient tissue from a soft tissue or metastatic bone lesion (measuring 1.5cm in diameter at computed tomography (CT) or magnetic resonance imaging (MRI) scan) available for organic anion-transporting polypeptide 1B3 (OATP1B3) immunohistochemistry (IHC) or must have a soft tissue or metastatic bone lesion that can be biopsied and be willing to undergo percutaneous biopsy to obtain tissue for OATP1B3 expression.

Eovist: 0.1 ml/kg Eovist will be administered intravenous (IV) to each patient

Localized disease: must have image guided biopsy confirmed prostate cancer and sufficient tissue available for OATP1B3 IHC.

Eovist: 0.1 ml/kg Eovist will be administered intravenous (IV) to each patient

Total of all reporting groups
Overall Number of Baseline Participants 12 12 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
5
  41.7%
3
  25.0%
8
  33.3%
>=65 years
7
  58.3%
9
  75.0%
16
  66.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 12 participants 24 participants
67.16  (9.52) 68.67  (6.31) 67.91  (7.91)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
12
 100.0%
12
 100.0%
24
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
12
 100.0%
12
 100.0%
24
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   8.3%
1
   4.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  25.0%
2
  16.7%
5
  20.8%
White
9
  75.0%
9
  75.0%
18
  75.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 12 participants 12 participants 24 participants
12
 100.0%
12
 100.0%
24
 100.0%
1.Primary Outcome
Title Uptake and Retention of Eovist in Prostate Cancers
Hide Description Uptake and retention of Eovist in prostate cancers is measured by the change of magnetic resonance imaging (MRI) parameter values between pre and post injection.
Time Frame Baseline and 20 minutes after Evoist injection
Hide Outcome Measure Data
Hide Analysis Population Description
Three patients did not complete the study and are excluded, and two patients were not evaluable due to non-evaluable images.
Arm/Group Title Participants With Advanced Disease Participants With Localized Disease
Hide Arm/Group Description:

Advanced disease: who have failed hormone therapy and who have sufficient tissue from a soft tissue or metastatic bone lesion (measuring 1.5cm in diameter at computed tomography (CT) or magnetic resonance imaging (MRI) scan) available for organic anion-transporting polypeptide 1B3 (OATP1B3) immunohistochemistry (IHC) or must have a soft tissue or metastatic bone lesion that can be biopsied and be willing to undergo percutaneous biopsy to obtain tissue for OATP1B3 expression.

Eovist: 0.1 ml/kg Eovist will be administered intravenous (IV) to each patient

Localized disease: must have image guided biopsy confirmed prostate cancer and sufficient tissue available for OATP1B3 IHC.

Eovist: 0.1 ml/kg Eovist will be administered intravenous (IV) to each patient

Overall Number of Participants Analyzed 9 10
Mean (Standard Deviation)
Unit of Measure: contrast enhancement ratio (CER)
Baseline 2.01  (1.16) 1.857  (0.41)
20 minutes after Eovist 2.52  (1.26) 2.212  (0.36)
2.Secondary Outcome
Title Number of Participants Who Were Evaluated for Magnetic Resonance (MR) Contrast Enhancement Parameters Following Eovist Injection With Respect to Gleason Score
Hide Description Scans with or without endorectal coil were obtained through the prostate gland, bone metastasis or soft tissue metastasis (usually a lymph node) selected as the target lesion as described in primary outcome measure. Then 0.1 ml/kg Eovist was administered intravenously. Scans were correlated with baseline Gleason score obtained from the prostate biopsy. Gleason score <7 = low grade cancer; Gleason score ≥7 = high grade cancer.
Time Frame At baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Three patients did not complete the study and are excluded, and two patients were not evaluable due to non-evaluable images.
Arm/Group Title Participants With Advanced Disease Participants With Localized Disease
Hide Arm/Group Description:

Advanced disease: who have failed hormone therapy and who have sufficient tissue from a soft tissue or metastatic bone lesion (measuring 1.5cm in diameter at computed tomography (CT) or magnetic resonance imaging (MRI) scan) available for organic anion-transporting polypeptide 1B3 (OATP1B3) immunohistochemistry (IHC) or must have a soft tissue or metastatic bone lesion that can be biopsied and be willing to undergo percutaneous biopsy to obtain tissue for OATP1B3 expression.

Eovist: 0.1 ml/kg Eovist will be administered intravenous (IV) to each patient

Localized disease: must have image guided biopsy confirmed prostate cancer and sufficient tissue available for OATP1B3 IHC.

Eovist: 0.1 ml/kg Eovist will be administered intravenous (IV) to each patient

Overall Number of Participants Analyzed 9 10
Measure Type: Count of Participants
Unit of Measure: Participants
Gleason score <7
0
   0.0%
1
  10.0%
Gleason score ≥7
9
 100.0%
9
  90.0%
3.Secondary Outcome
Title Baseline Serum Prostate-Specific Antigen (PSA) Levels of Patients Who Were Evaluated for Magnetic Resonance (MR) Contrast Enhancement Parameters Following Eovist Injection
Hide Description Scans with or without endorectal coil were obtained through the prostate gland, bone metastasis or soft tissue metastasis (usually a lymph node) selected as the target lesion as described in primary outcome measure. Then 0.1 ml/kg Eovist was administered intravenously. Scans were correlated to baseline PSA levels.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Three patients did not complete the study and are excluded, and two patients were not evaluable due to non-evaluable images.
Arm/Group Title Participants With Advanced Disease Participants With Localized Disease
Hide Arm/Group Description:

Advanced disease: who have failed hormone therapy and who have sufficient tissue from a soft tissue or metastatic bone lesion (measuring 1.5cm in diameter at computed tomography (CT) or magnetic resonance imaging (MRI) scan) available for organic anion-transporting polypeptide 1B3 (OATP1B3) immunohistochemistry (IHC) or must have a soft tissue or metastatic bone lesion that can be biopsied and be willing to undergo percutaneous biopsy to obtain tissue for OATP1B3 expression.

Eovist: 0.1 ml/kg Eovist will be administered intravenous (IV) to each patient

Localized disease: must have image guided biopsy confirmed prostate cancer and sufficient tissue available for OATP1B3 IHC.

Eovist: 0.1 ml/kg Eovist will be administered intravenous (IV) to each patient

Overall Number of Participants Analyzed 9 10
Mean (Standard Deviation)
Unit of Measure: ng/mL
134.14  (197.36) 12.97  (14.99)
4.Secondary Outcome
Title Number of Participants With Serious and Non-serious Adverse Events
Hide Description Here is the number of participants with serious and non-serious adverse events assessed by the Common Terminology Criteria in Adverse Events (CTCAE v4.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned.
Time Frame From date treatment consent signed to date off study, approximately 3 years and 33 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Participants With Advanced Disease Participants With Localized Disease
Hide Arm/Group Description:

Advanced disease: who have failed hormone therapy and who have sufficient tissue from a soft tissue or metastatic bone lesion (measuring 1.5cm in diameter at computed tomography (CT) or magnetic resonance imaging (MRI) scan) available for organic anion-transporting polypeptide 1B3 (OATP1B3) immunohistochemistry (IHC) or must have a soft tissue or metastatic bone lesion that can be biopsied and be willing to undergo percutaneous biopsy to obtain tissue for OATP1B3 expression.

Eovist: 0.1 ml/kg Eovist will be administered intravenous (IV) to each patient

Localized disease: must have image guided biopsy confirmed prostate cancer and sufficient tissue available for OATP1B3 IHC.

Eovist: 0.1 ml/kg Eovist will be administered intravenous (IV) to each patient

Overall Number of Participants Analyzed 12 12
Measure Type: Count of Participants
Unit of Measure: Participants
1
   8.3%
0
   0.0%
Time Frame From date treatment consent signed to date off study, approximately 3 years and 33 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Participants With Advanced Disease Participants With Localized Disease
Hide Arm/Group Description

Advanced disease: who have failed hormone therapy and who have sufficient tissue from a soft tissue or metastatic bone lesion (measuring 1.5cm in diameter at computed tomography (CT) or magnetic resonance imaging (MRI) scan) available for organic anion-transporting polypeptide 1B3 (OATP1B3) immunohistochemistry (IHC) or must have a soft tissue or metastatic bone lesion that can be biopsied and be willing to undergo percutaneous biopsy to obtain tissue for OATP1B3 expression.

Eovist: 0.1 ml/kg Eovist will be administered intravenous (IV) to each patient

Localized disease: must have image guided biopsy confirmed prostate cancer and sufficient tissue available for OATP1B3 IHC.

Eovist: 0.1 ml/kg Eovist will be administered intravenous (IV) to each patient

All-Cause Mortality
Participants With Advanced Disease Participants With Localized Disease
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)      0/12 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Participants With Advanced Disease Participants With Localized Disease
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/12 (0.00%)      0/12 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Participants With Advanced Disease Participants With Localized Disease
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/12 (8.33%)      0/12 (0.00%)    
Gastrointestinal disorders     
Nausea  1  1/12 (8.33%)  1 0/12 (0.00%)  0
1
Term from vocabulary, CTCAE (4.0)
Indicates events were collected by systematic assessment
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: Dr. Ismail Baris Turkbey
Organization: National Cancer Institute
Phone: 301-443-2315
EMail: turkbey@nih.gov
Layout table for additonal information
Responsible Party: Ismail B. Turkbey, National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01867424     History of Changes
Other Study ID Numbers: 130145
13-C-0145
First Submitted: May 31, 2013
First Posted: June 4, 2013
Results First Submitted: November 8, 2017
Results First Posted: March 20, 2018
Last Update Posted: March 20, 2018