UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028870 |
|---|---|
| Receipt number | R000032791 |
| Scientific Title | Comparison of Contrast-Enhanced Ultrasonography with Gd-EOB-DTPA-enhanced MRI for the Diagnosis of Liver Metastases from Pancreatic Cancer |
| Date of disclosure of the study information | 2017/08/28 |
| Last modified on | 2021/08/04 21:16:57 |
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Basic information
Public title
Comparison of Contrast-Enhanced Ultrasonography with Gd-EOB-DTPA-enhanced MRI for the Diagnosis of Liver Metastases from Pancreatic Cancer
Acronym
Comparison of Contrast-Enhanced Ultrasonography with enhanced MRI for the Diagnosis of Liver Metastases from Pancreatic Cancer
Scientific Title
Comparison of Contrast-Enhanced Ultrasonography with Gd-EOB-DTPA-enhanced MRI for the Diagnosis of Liver Metastases from Pancreatic Cancer
Scientific Title:Acronym
Comparison of Contrast-Enhanced Ultrasonography with enhanced MRI for the Diagnosis of Liver Metastases from Pancreatic Cancer
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare contrast enhanced ultrasonography using Sonazoid with Gd EOB DTPA enhanced MRI in the diagnosis of liver metastases in patients with pancreatic cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The diagnostic accuracies of CEUS compared with EOB MRI for liver metastases from pancreatic cancer
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
An intravenous bolus injection of Sonazoid
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
cases of suspected of having a pancreatic cancer by contrast enhanced CT
Key exclusion criteria
serious complications
severe mental illness
allergy of egg or Sonazoid
non-agreement case with this research
unsuitable case
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Yoshinki |
| Middle name | |
| Last name | Hirooka |
Organization
Nagoya University Hospital
Division name
Department of Endoscopy
Zip code
466-0065
Address
65 Tsurumai-cho,Showa-ku,Nagoya
TEL
052-744-2602
hirooka@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Ishikawa |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of gastroenterology and Hepatology
Zip code
466-0065
Address
65 Tsurumai-cho,Showa-ku,Nagoya
TEL
052-744-2602
Homepage URL
ishitaku@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine Department of gastroenterology and Hepatology
Institute
Department
Personal name
Funding Source
Organization
no organization
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University Graduate School of Medicine Ethics committee
Address
65 Tsurumai-cho,Showa-ku,Nagoya
Tel
052-744-2973
ethics@med.nagoya-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2017 | Year | 08 | Month | 13 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 31 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 13 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 08 | Month | 28 | Day |
Last modified on
| 2021 | Year | 08 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032791
