UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054232 |
|---|---|
| Receipt number | R000061897 |
| Scientific Title | Study on Hemodynamic Analysis of the Portal Venous Region Using 3D cine Phase Contrast MRI (4D Flow MRI) and Its Association with Prognosis and Treatment Efficacy |
| Date of disclosure of the study information | 2024/07/01 |
| Last modified on | 2025/10/20 12:11:28 |
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Basic information
Public title
Study on Hemodynamic Analysis of the Portal Venous Region Using 3D cine Phase Contrast MRI (4D Flow MRI) and Its Association with Prognosis and Treatment Efficacy
Acronym
4D MRI Portal Hemodynamics Study
Scientific Title
Study on Hemodynamic Analysis of the Portal Venous Region Using 3D cine Phase Contrast MRI (4D Flow MRI) and Its Association with Prognosis and Treatment Efficacy
Scientific Title:Acronym
Portal Venous 4D Flow MRI Analysis Study
Region
| Japan |
Condition
Condition
Liver diseases in general
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To analyze the presence and extent of portosystemic shunting and its impact on survival outcomes using 4D Flow MRI to evaluate hemodynamic characteristics in the portal venous system.
To elucidate the distribution of intrahepatic portal blood flow using 4D Flow MRI and explore its relationship with the intraliver distribution of chemotherapeutic agents and their therapeutic effects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Survival outcomes
2. Reduction in liver tumor size (according to RECIST criteria)
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Adult patients who are capable of understanding the contents of the research.
2. Patients with various degrees of portosystemic shunt and a control group of patients without portosystemic shunt. All are scheduled for abdominal contrast-enhanced MRI at our hospital for routine clinical purposes, such as the diagnosis and assessment of hepatocellular carcinoma, hepatic hemangiomas, metastatic liver tumors, shunts, and other tumors.
3. Patients scheduled for chemotherapy for primary liver tumors or metastatic liver tumors. All are regularly scheduled for abdominal contrast-enhanced MRI for routine clinical evaluation of primary or metastatic tumors.
4. Additionally, individuals who participated in the studies "Research on human vascular hemodynamics analysis using three-dimensional cine phase-contrast magnetic resonance imaging method (jRCTs041180157)" and "Hemodynamic study of the portal venous region using 3D cine phase contrast MRI(4D Flow MRI)(Approval number 2023-0140)" and have consented to the secondary use of their data for future research (must meet the criteria outlined in 2 or 3 above).
Key exclusion criteria
Individuals who have declined to participate in the study, those with contraindications for MRI such as metallic implants in the body or claustrophobia, and those who find it difficult to remain still for about an hour.
Target sample size
216
Research contact person
Name of lead principal investigator
| 1st name | Ryota |
| Middle name | |
| Last name | Hyodo |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Fundamental Development for Advanced Low Invasive Diagnostic Imaging
Zip code
466-8560
Address
65, Tsurumai-tyo, Showa-Ku, Nagoya-city, Aichi-ken
TEL
0527442327
hyodo.ryota.w3@f.mail.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryota |
| Middle name | |
| Last name | Hyodo |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Fundamental Development for Advanced Low Invasive Diagnostic Imaging
Zip code
466-8560
Address
65, Tsurumai-tyo, Showa-Ku, Nagoya-city, Aichi-ken
TEL
0527442327
Homepage URL
hyodo.ryota.w3@f.mail.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Department of Fundamental Development for Advanced Low Invasive Diagnostic Imaging
Ryota Hyodo
Institute
Department
Personal name
Funding Source
Organization
JSPS KAKENHI
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Nagoya University Hospital
Address
65, Tsurumai-tyo, Showa-Ku, Nagoya-city, Aichi-ken
Tel
0527412111
cre@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
| 2024 | Year | 07 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 04 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2034 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not applicable
Management information
Registered date
| 2024 | Year | 04 | Month | 23 | Day |
Last modified on
| 2025 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061897
