UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000015597
Receipt No. R000017506
Scientific Title Evaluation of the tumor blood flow by computed tomography(CT)perfusion imaging and an effect of chemotherapy or radiotherapy for esophageal cancer
Date of disclosure of the study information 2014/11/04
Last modified on 2018/11/07

* 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 the tumor blood flow by computed tomography(CT)perfusion imaging and an effect of chemotherapy or radiotherapy for esophageal cancer
Acronym Tumor blood flow by CT perfusion imaging and effect of treatment
Scientific Title Evaluation of the tumor blood flow by computed tomography(CT)perfusion imaging and an effect of chemotherapy or radiotherapy for esophageal cancer
Scientific Title:Acronym Tumor blood flow by CT perfusion imaging and effect of treatment
Region
Japan

Condition
Condition esophageal cancer
Classification by specialty
Gastrointestinal surgery Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The object is to establish the relationship between the tumor blood flow by CT perfusion imaging and an effect of chemotherapy or radiotherapy for esophageal cancer. Pretreatment tumor blood flow by using CT perfusion imaging wil be expect to indicate a prediction of the efficacy in these treatments.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlation between tumor blood flow before chemotherapy or radiotherapy and clinical effect of these therapy.

Evaluate to change of tumor blood flow before and after the therapies.
Key secondary outcomes Correlation between tumor blood flow and short-term prognosis

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 If the patients who will undergo chemotherapy or radiotherapy, they have to be taken CT Perfusion imaging twice (before and after therapy)

Scan protocol : 80kV,60-100mA, 0.5sec/rot, 0.5mm*320(scan range) , 20scans

contrast medium : iohexol or iopamidole, iomeprol
50ml (all patient)

If the patients received surgery alone, he will be taken CT perfusion imaging just one time before operation.
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

Not applicable
Gender Male and Female
Key inclusion criteria Untreated esophageal cancer, tumor depth is T1 or more. (TNM UICC ver7)

Patients who can be undergone CT perfusion imaging

Written informed concent by themselves
Key exclusion criteria Patients who has been treated for esophageal cancer before

Patienst who is unable to take CT Perfusion imaging by severe renal failure and iodine allergy

Pregnant and lactating woman
Target sample size 80

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Takashi Kamei
Organization Tohoku University Graduate School of Medicine
Division name Division of Advanced Surgical Science and Technology
Zip code
Address 1-1 Seiryo, Aoba-ku, Sendai, Miyagi, Japan 980-8574
TEL 022-717-7214
Email tkamei@med.tohoku.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Yu Onodera
Organization Tohoku University Graduate School of Medicine
Division name Division of Advanced Surgical Science and Technology
Zip code
Address 1-1 Seiryo, Aoba-ku, Sendai, Miyagi, Japan 980-8574
TEL 022-717-7214
Homepage URL
Email yu_con_gray@hotmail.com

Sponsor
Institute Tohoku University Graduate School of Medicine
Institute
Department

Funding Source
Organization None
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
Address
Tel
Email

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
2014 Year 11 Month 04 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
2014 Year 10 Month 28 Day
Date of IRB
Anticipated trial start date
2014 Year 10 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 11 Month 04 Day
Last modified on
2018 Year 11 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017506

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.