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

Email

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


Email

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

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name