UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015597 |
|---|---|
| Receipt number | 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 | 2023/05/16 13:36:35 |
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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
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Kamei |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of Advanced Surgical Science and Technology
Zip code
980-8574
Address
1-1 Seiryo, Aoba-ku, Sendai, Miyagi, Japan 980-8574
TEL
022-717-7214
tkamei@med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Yu |
| Middle name | |
| Last name | Onodera |
Organization
Tohoku University Graduate School of Medicine
Division name
Division of Advanced Surgical Science and Technology
Zip code
980-8574
Address
1-1 Seiryo, Aoba-ku, Sendai, Miyagi, Japan 980-8574
TEL
022-717-7214
Homepage URL
yu_con_gray@hotmail.com
Sponsor or person
Institute
Tohoku University Graduate School of Medicine
Institute
Department
Personal name
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
Clinical Research, Innovation and Education Center, Tohoku University Hospital
Address
1-1 Seiryo, Aoba-ku, Sendai, Miyagi, Japan 980-8574
Tel
022-717-7122
med-kenkyo@bureau.tohoku.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
| 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
50
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
Completed
Date of protocol fixation
| 2014 | Year | 10 | Month | 28 | Day |
Date of IRB
| 2014 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2014 | Year | 10 | Month | 28 | Day |
Last follow-up date
| 2022 | 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
| 2014 | Year | 11 | Month | 04 | Day |
Last modified on
| 2023 | Year | 05 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017506
