Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 36 of 40 for:    "Klatskin tumor"

The Role of Gadoxetate (Eovist) Enhanced CT in Evaluating Cholangiocarcinoma

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.
ClinicalTrials.gov Identifier: NCT01673802
Recruitment Status : Completed
First Posted : August 28, 2012
Results First Posted : June 20, 2014
Last Update Posted : June 1, 2017
Sponsor:
Collaborator:
Society of Abdominal Radiology
Information provided by (Responsible Party):
John V. Thomas, University of Alabama at Birmingham

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Cholangiocarcinoma
Intervention Drug: CT scan
Enrollment 18
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Gadoxetate Uptake in CT Imaging
Hide Arm/Group Description Patients will undergo a standard of care Gadoxetate (Eovist 0.025 mmol/kg) MRI for cholangiocarcinoma. Patients will then be immediately placed on the CT scanner. Patients will undergo a dual energy CT of the abdomen with no additional contrast. After the first 8 subjects were accrued, it was apparent that the standard clinical dose was suboptimal for visualization on rsDECT. After obtaining additional regulatory approvals including an investigative New Drug (IND) letter from the FDA, as well as new approval from our institution's IRB, all subsequent subjects were scanned with 0.05 mmol/kg Gadoxetate Disodium. Both groups were injected with Gadoxetate Disodium at a rate of 1 ml/s.
Period Title: Gadoxetate Standard Dose 0.025 mmol/kg
Started 8
Completed 8
Not Completed 0
Period Title: Gadoxetate Double Dose 0.050 mmol/kg
Started 10
Completed 10
Not Completed 0
Arm/Group Title Gadoxetate Uptake in CT Imaging
Hide Arm/Group Description Patients will undergo a standard of care Gadoxetate (Eovist 0.025 mmol/kg) MRI for cholangiocarcinoma. Patients will then be immediately placed on the CT scanner. Patients will undergo a dual energy CT of the abdomen with no additional contrast. After the first 8 subjects were accrued, it was apparent that the standard clinical dose was suboptimal for visualization on rsDECT. After obtaining additional regulatory approvals including an investigative New Drug (IND) letter from the FDA, as well as new approval from our institution's IRB, all subsequent subjects were scanned with 0.05 mmol/kg Gadoxetate Disodium. Both groups were injected with Gadoxetate Disodium at a rate of 1 ml/s.
Overall Number of Baseline Participants 18
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 18 participants
54.9
(31 to 81)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 18 participants
Female
7
  38.9%
Male
11
  61.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 18 participants
18
1.Primary Outcome
Title Number of Subjects Where Hilar Cholangiocarcinomas Could be Visualized Using Gadoxetate Disodium Enhanced Dual Energy CT
Hide Description CT scans were assessed for tumor visualization after use of Gadoxetate disodium
Time Frame 24 hrs
Hide Outcome Measure Data
Hide Analysis Population Description
Number of Subjects Where Hilar Cholangiocarcinomas Could be Visualized Using Gadoxetate Disodium Enhanced Dual Energy CT
Arm/Group Title Gadoxetate Uptake in CT Imaging
Hide Arm/Group Description:
Patients will undergo a standard of care Gadoxetate (Eovist 0.025 mmol/kg) MRI for cholangiocarcinoma. Patients will then be immediately placed on the CT scanner. Patients will undergo a dual energy CT of the abdomen with no additional contrast. After the first 8 subjects were accrued, it was apparent that the standard clinical dose was suboptimal for visualization on rsDECT. After obtaining additional regulatory approvals including an investigative New Drug (IND) letter from the FDA, as well as new approval from our institution's IRB, all subsequent subjects were scanned with 0.05 mmol/kg Gadoxetate Disodium. Both groups were injected with Gadoxetate Disodium at a rate of 1 ml/s.
Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: participants
5
Time Frame Baseline to 24 hours
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Gadoxetate Uptake in CT Imaging
Hide Arm/Group Description Patients will undergo a standard of care Gadoxetate (Eovist 0.025 mmol/kg) MRI for cholangiocarcinoma. Patients will then be immediately placed on the CT scanner. Patients will undergo a dual energy CT of the abdomen with no additional contrast. After the first 8 subjects were accrued, it was apparent that the standard clinical dose was suboptimal for visualization on rsDECT. After obtaining additional regulatory approvals including an investigative New Drug (IND) letter from the FDA, as well as new approval from our institution's IRB, all subsequent subjects were scanned with 0.05 mmol/kg Gadoxetate Disodium. Both groups were injected with Gadoxetate Disodium at a rate of 1 ml/s.
All-Cause Mortality
Gadoxetate Uptake in CT Imaging
Affected / at Risk (%)
Total   0/18 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Gadoxetate Uptake in CT Imaging
Affected / at Risk (%)
Total   0/18 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Gadoxetate Uptake in CT Imaging
Affected / at Risk (%)
Total   0/18 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: John V. Thomas, MD; Principal Investigator
Organization: University of Alabama at Bimringham
Phone: 205-996-4132
Responsible Party: John V. Thomas, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01673802     History of Changes
Other Study ID Numbers: R11-153
117354 ( Other Identifier: FDA )
First Submitted: August 13, 2012
First Posted: August 28, 2012
Results First Submitted: May 20, 2014
Results First Posted: June 20, 2014
Last Update Posted: June 1, 2017