UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035896 |
|---|---|
| Receipt number | R000040892 |
| Scientific Title | Evaluation of detection and characterization of liver tumor with 3D rapid acquisition sequence with compressed sensing |
| Date of disclosure of the study information | 2019/02/17 |
| Last modified on | 2019/08/18 11:49:12 |
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Basic information
Public title
Evaluation of detection and characterization of liver tumor with 3D rapid acquisition sequence with compressed sensing
Acronym
Efficacy of 3D high speed imaging method with compressed sensing for liver tumors
Scientific Title
Evaluation of detection and characterization of liver tumor with 3D rapid acquisition sequence with compressed sensing
Scientific Title:Acronym
Efficacy of 3D high speed imaging method with compressed sensing for liver tumors
Region
| Japan |
Condition
Condition
liver tumor
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of detection and characterization of liver tumor using 3D dynamic MRI with compressed sensing
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accuracy for detection of hypervascular hepatocellular carcinoma.
Accuracy for characterization of enhance,ent pattern of tumor.
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
| Device,equipment |
Interventions/Control_1
Contrast enhanced MRI
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Patients whose liver tumor was pointed out by CT or ultrasound and examined necessary for MRI.
2. High risk patients with hepatocellular carcinoma with chronic liver disease.
3. Transcatheteric embolization or radiofrequency ablation therapy for hepatocellular carcinoma was performed, and examination was made based on follow-up observation.
4. Patient with colorectal cancer or pancreatic cancer for the purpose of examining metastatic liver cancer.
5. Over 20 years old.
6. Gender does not matter.
Key exclusion criteria
1. Patients with allergic history with bronchial asthma or past nonspecific extracellular fluid contrast agents or hepatocyte specific contrast agents.
2. Patients with impaired renal function.
3. Patients with internal metals.
4. Claustrophobia.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiro |
| Middle name | |
| Last name | Saito |
Organization
Tokyo Medical University
Division name
Radiology
Zip code
160-0023
Address
6-7-1, Nishi-Shinjuku, Shinjuku-ku, Tokyo
TEL
03-3342-6111
saito-k@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Kazuiro |
| Middle name | |
| Last name | Saito |
Organization
Tokyo Medical University
Division name
Radiology
Zip code
160-0023
Address
6-7-1, Nishi-Shinjuku, Shinjuku-ku, Tokyo
TEL
03-3342-6111
Homepage URL
saito-k@tokyo-med.acjp
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical University
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
Center for Research Administration and Innovation, Tokyo Medical University
Address
6-7-1, Nishi-Shinjuku, Shinjuku-ku, Tokyo
Tel
03-3342-6111
Adm_IRB@tokyo-med.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
| 2019 | Year | 02 | Month | 17 | 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
| 2018 | Year | 05 | Month | 28 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 10 | Day |
Last follow-up date
| 2019 | Year | 12 | 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
| 2019 | Year | 02 | Month | 16 | Day |
Last modified on
| 2019 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040892
