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Trial record 10 of 44 for:    Gadoxetate

Efficacy and Safety of Primovist in Chinese Patients

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ClinicalTrials.gov Identifier: NCT00526188
Recruitment Status : Completed
First Posted : September 10, 2007
Results First Posted : December 30, 2009
Last Update Posted : May 1, 2015
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Known or Suspected Focal Liver Lesions
Intervention Drug: Gadoxetic Acid Disodium (Primovist, BAY86-4873)
Enrollment 234
Recruitment Details The recruitment period was 20 Aug 2007 to 30 Aug 2008.
Pre-assignment Details 247 Chinese patients were recruited and screened. Among these, 13 patients were screening failures: withdrawal of consent (7 patients), non-fulfillment of the inclusion and exclusion criteria (3 patients), other reasons (3 patients). The remaining 234 patients received the study drug and were included in the safety analysis set.
Arm/Group Title Gadoxetic Acid Disodium (Primovist, BAY86-4873)
Hide Arm/Group Description Bolus injection of 0.025 mmol/kg body weight (0.1 ml/kg BW) of Gadoxetic Acid Disodium (Primovist, BAY86-4873). Single i.v. injection during MRI procedure, with one contrast-enhanced MRI procedure per patient
Period Title: Overall Study
Started 234
Completed 234
Not Completed 0
Arm/Group Title Gadoxetic Acid Disodium (Primovist, BAY86-4873)
Hide Arm/Group Description Bolus injection of 0.025 mmol/kg body weight (0.1 ml/kg BW) of Gadoxetic Acid Disodium (Primovist, BAY86-4873). Single i.v. injection during MRI procedure, with one contrast-enhanced MRI procedure per patient
Overall Number of Baseline Participants 234
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 234 participants
50.2  (11.78)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 234 participants
Female
79
  33.8%
Male
155
  66.2%
Characterization of first liver lesion type of referral diagnosis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 234 participants
Hepatocellular carcinoma 47
Cholangiocarcinoma 1
Metastasis 58
Focal nodular hyperplasia 14
Hemangioma 42
Abscess 2
Focal fatty infiltration 1
Liver cyst 13
Inflammation 1
Harmatoma 1
Infection 1
Inflammatory pseudotumor 2
Not assessable 51
Characterization of second liver lesion type of referral diagnosis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 234 participants
No second liver lesion type 191
Hepatocellular carcinoma 3
Metastasis 5
Hemangioma 7
Hydatid cyst 1
Liver cyst 23
Calcification 1
Inflammatory pseudotumor 1
Not assessable 2
Characterization of third liver lesion type of referral diagnosis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 234 participants
No third liver lesion type 231
Hemangioma 1
Liver cyst 1
Calcification 1
1.Primary Outcome
Title Difference in Sensitivity of Lesion Detection in MRI Images (Post-contrast MRI Minus Pre-contrast MRI) Measured as Percentage Points
Hide Description Three Blinded Readers performed lesion detection in pre- and post-contrast MRI image sets. Per Blinded Reader/image set combination, sensitivity of lesion detection was calculated, as: (number of lesions detected in the reader/image set combination)/(number of lesions in Standard of Reference)*100%. Then, difference in sensitivity of lesion detection for post- minus pre-contrast MRI images (in percentage points) was calculated for each Blinded Reader.
Time Frame Post administration assessment of study images (i.e. on the same day of treatment by the investigators and at the end of patient enrollment of the study from 29 September to 18 November 2008 by the Blinded Readers).
Hide Outcome Measure Data
Hide Analysis Population Description
All participants from the per protocol set with pre- and post-contrast MRI image sets evaluable for all blinded readers, with at least 1 lesion in the Standard of Reference (SOR)
Arm/Group Title Gadoxetic Acid Disodium (Primovist, BAY86-4873)
Hide Arm/Group Description:
Bolus injection of 0.025 mmol/kg body weight (0.1 ml/kg BW) of Gadoxetic Acid Disodium (Primovist, BAY86-4873). Single i.v. injection during MRI procedure, with one contrast-enhanced MRI procedure per patient
Overall Number of Participants Analyzed 176
Mean (95% Confidence Interval)
Unit of Measure: Percentage points
BR 1: Dif. in sens. post- minus pre-contrast MRI
8.65
(4.82 to 12.47)
BR 2: Dif. in sens. post- minus pre-contrast MRI
12.23
(7.60 to 16.87)
BR 3: Dif. in sens. post- minus pre-contrast MRI
7.50
(2.84 to 12.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gadoxetic Acid Disodium (Primovist, BAY86-4873)
Comments Difference in sensitivity of lesion detection between post- and pre-contrast MRI image set was calculated. Null hypothesis: No difference between post- and pre-contrast MRI image set. Test was performed based on a normal-approximated confidence interval (CI) for the average blinded reader difference. This CI had a confidence level of 95% and was two-sided. The study was planned with a power of 80%.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Test performed based on the 95% CI
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 9.46
Confidence Interval 95%
6.00 to 12.93
Estimation Comments Comparison was post-contrast MRI minus pre-contrast MRI
2.Secondary Outcome
Title Difference in Sensitivity of Lesion Detection in MRI Images (Post-contrast MRI Minus Pre-contrast MRI) Assessed by Investigators Measured in Percentage Points
Hide Description The on-site investigators performed lesion detection in pre- and post-contrast MRI image sets. Per image set, sensitivity of lesion detection was calculated, as: (number of lesions detected in image set)/(number of lesions in Standard of Reference)*100%. Then, difference in sensitivity of lesion detection for post- minus pre-contrast MRI (in percentage points) was calculated.
Time Frame Post administration assessment of study images (i.e. on the same day of treatment by the investigators and at the end of patient enrollment of the study from 29 September to 18 November 2008 by the Blinded Readers).
Hide Outcome Measure Data
Hide Analysis Population Description
All participants from the per protocol set, with at least 1 lesion in the Standard of Reference (SOR).
Arm/Group Title Gadoxetic Acid Disodium (Primovist, BAY86-4873)
Hide Arm/Group Description:
Bolus injection of 0.025 mmol/kg body weight (0.1 ml/kg BW) of Gadoxetic Acid Disodium (Primovist, BAY86-4873). Single i.v. injection during MRI procedure, with one contrast-enhanced MRI procedure per patient
Overall Number of Participants Analyzed 177
Mean (95% Confidence Interval)
Unit of Measure: Percentage points
4.81
(1.84 to 7.78)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gadoxetic Acid Disodium (Primovist, BAY86-4873)
Comments Difference in sensitivity of lesion detection between post- and pre-contrast MRI image sets, based on investigators assessments was calculated. Null hypothesis: No difference between post and pre contrast MRI image set. Test was performed based on a normal-approximated confidence interval (CI) for the investigators difference. This CI had a confidence level of 95% and was two-sided.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Test performed based on the 95% CI
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 4.81
Confidence Interval 95%
1.84 to 7.78
Estimation Comments Comparison was post-contrast MRI minus pre-contrast MRI (for investigator's result)
3.Secondary Outcome
Title Difference in Precision of Lesion Characterization (Combined Pre- and Post-contrast Minus Pre-contrast MRI) Measured in Percentage Points
Hide Description Three Blinded Reader performed lesion characterization in pre- and combined pre-/post-contrast MRI image set. Per Blinded Reader/image set combination, precision of lesion characterization was calculated: (number of unique Standard of Reference-matched characterizations detected for the Reader/image set combination)/(number of unique lesion characterizations in Standard of Reference)*100%. Then, difference in precision of lesion characterization for post- minus combined pre-/post-contrast MRI (in percentage points) was calculated for each Blinded Reader.
Time Frame Post administration assessment of study images (i.e. on the same day of treatment by the investigators and at the end of patient enrollment of the study from 29 September to 18 November 2008 by the Blinded Readers).
Hide Outcome Measure Data
Hide Analysis Population Description
All participants from the per protocol set with pre- and combined pre- and post- contrast MRI image sets evaluable for all blinded readers, with at least 1 lesion characterization in the Standard of reference (SOR)
Arm/Group Title Gadoxetic Acid Disodium (Primovist, BAY86-4873)
Hide Arm/Group Description:
Bolus injection of 0.025 mmol/kg body weight (0.1 ml/kg BW) of Gadoxetic Acid Disodium (Primovist, BAY86-4873). Single i.v. injection during MRI procedure, with one contrast-enhanced MRI procedure per patient
Overall Number of Participants Analyzed 165
Mean (95% Confidence Interval)
Unit of Measure: Percentage points
BR1: Dif. in prec. pre-/post- minus pre-contrast
13.64
(7.80 to 19.47)
BR2: Dif. in prec. pre-/post- minus pre-contrast
9.55
(3.13 to 15.96)
BR3: Dif. in prec. pre-/post- minus pre-contrast
10.91
(5.32 to 16.50)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gadoxetic Acid Disodium (Primovist, BAY86-4873)
Comments Difference in precision of lesion characterization between combined pre and post contrast MRI and pre contrast MRI image set was calculated. Null hypothesis: No difference between combined pre- and post-contrast MRI and pre contrast MRI image set. Test was performed based on a normal-approximated confidence interval (CI) for the average blinded reader difference. This CI had a confidence level of 95% and was two-sided.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method Test performed based on the 95% CI
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 11.36
Confidence Interval 95%
7.45 to 15.28
Estimation Comments Comparison was combined pre- and post-contrast MRI minus pre-contrast MRI
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Gadoxetic Acid Disodium (Primovist, BAY86-4873)
Hide Arm/Group Description Bolus injection of 0.025 mmol/kg body weight (0.1 ml/kg BW) of Gadoxetic Acid Disodium (Primovist, BAY86-4873). Single i.v. injection during MRI procedure, with one contrast-enhanced MRI procedure per patient
All-Cause Mortality
Gadoxetic Acid Disodium (Primovist, BAY86-4873)
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Gadoxetic Acid Disodium (Primovist, BAY86-4873)
Affected / at Risk (%)
Total   0/234 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Gadoxetic Acid Disodium (Primovist, BAY86-4873)
Affected / at Risk (%)
Total   20/234 (8.55%) 
Gastrointestinal disorders   
Nausea * 1  2/234 (0.85%) 
General disorders   
Injection site pain * 1  1/234 (0.43%) 
Investigations   
Blood pressure systolic increased * 1  1/234 (0.43%) 
Blood pressure diastolic increased * 1  1/234 (0.43%) 
Blood lactate dehydrogenase increased * 1  3/234 (1.28%) 
Blood glucose increased * 1  2/234 (0.85%) 
White blood cell count decreased * 1  2/234 (0.85%) 
Blood bilirubin increased * 1  3/234 (1.28%) 
Blood phosphorus increased * 1  1/234 (0.43%) 
Alanine aminotransferase increased * 1  1/234 (0.43%) 
Aspartate aminotransferase increased * 1  1/234 (0.43%) 
Vascular disorders   
Hypertension * 1  4/234 (1.71%) 
Hypotension * 1  2/234 (0.85%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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: Therapeutic Area Head
Organization: BAYER
EMail: clinical-trials-contact@bayerhealthcare.com
Layout table for additonal information
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00526188     History of Changes
Other Study ID Numbers: 91531
310682 ( Other Identifier: Company internal )
First Submitted: September 6, 2007
First Posted: September 10, 2007
Results First Submitted: October 5, 2009
Results First Posted: December 30, 2009
Last Update Posted: May 1, 2015