UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035896
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email saito-k@tokyo-med.acjp

Sponsor
Institute Tokyo Medical University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040892

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.