UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043417
Receipt number R000049573
Scientific Title Study to optimize the timing for acquisition of venous phase in preoperative 3D-CT
Date of disclosure of the study information 2021/02/22
Last modified on 2022/09/07 23:35:19

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Basic information

Public title

Study to optimize the timing for acquisition of venous phase in preoperative 3D-CT

Acronym

Study to optimize the timing for acquisition of venous phase in preoperative 3D-CT

Scientific Title

Study to optimize the timing for acquisition of venous phase in preoperative 3D-CT

Scientific Title:Acronym

Study to optimize the timing for acquisition of venous phase in preoperative 3D-CT

Region

Japan


Condition

Condition

right-side colon cancer

Classification by specialty

Gastrointestinal surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate whether the peak of venous phase enhancement can be appropriately scanned by low dose monitoring for right-side colon cancer

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

CT value in venous phase

Key secondary outcomes

Timing of venous scan
CT value of parenchymal organs
Patient characteristics


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Device,equipment

Interventions/Control_1

CT scanned with patient-specific timing

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

Patients who are performed 3D-CT for right-side colon cancer

Key exclusion criteria

Previous surgical history for gastroenterological diseases
Inappropriate for enrollment
Informed consent is not obtained
Iodine allergy

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Ichiro
Middle name
Last name Takemasa

Organization

Sapporo Medical University

Division name

Department of Surgery, Surgical Oncology and Science

Zip code

060-8543

Address

S1 W16, Chuo-ku, Sapporo

TEL

011-611-2111

Email

itakemasa@sapmed.ac.jp


Public contact

Name of contact person

1st name Atsushi
Middle name
Last name Hamabe

Organization

Sapporo Medical University

Division name

Department of Surgery, Surgical Oncology and Science

Zip code

060-8543

Address

S1 W16, Chuo-ku, Sapporo

TEL

011-611-2111

Homepage URL


Email

ahamabe@sapmed.ac.jp


Sponsor or person

Institute

Sapporo Medical University

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Sapporo medical university hospital institutional review board

Address

291, South1 West16, Chuo-ku, Sapporo, Hokkaido

Tel

011-611-2111

Email

ji-rskk@sapmed.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

2021 Year 02 Month 22 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

2019 Year 09 Month 02 Day

Date of IRB

2020 Year 01 Month 14 Day

Anticipated trial start date

2020 Year 01 Month 16 Day

Last follow-up date

2022 Year 03 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

2021 Year 02 Month 22 Day

Last modified on

2022 Year 09 Month 07 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049573


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name