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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025762
Receipt No. R000029621
Scientific Title Dose reduction and image quality in low tube voltage CT colonography: evaluation the efficacy of SAFIRE
Date of disclosure of the study information 2017/01/25
Last modified on 2017/01/19

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Basic information
Public title Dose reduction and image quality in low tube voltage CT colonography: evaluation the efficacy of SAFIRE
Acronym SAFIRE CTC study
Scientific Title Dose reduction and image quality in low tube voltage CT colonography: evaluation the efficacy of SAFIRE
Scientific Title:Acronym SAFIRE CTC study
Region
Japan

Condition
Condition Healthy individual
Classification by specialty
Gastroenterology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Low tube voltage (100kVp) vs. low tube current (20mAs) in ultralow-dose CT colonography: Evaluation the feasibility of preserving image quality with iterative reconstruction (SAFIRE).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Image quality and noise assessments for CT colonography with iterative reconstruction (SAFIRE).
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 1) Healthy individual.
2) Major functions of organs of the subjects are in a good condition.
3) Aged 20 years or older.
Key exclusion criteria 1) Gastric or intestinal stenosis, abdominal adhesions, bowel obstruction or perforation, toxic megacolon.
2) Evidence of an increased risk in carrying out bowel preparation or CTC exams.
3) Possibility of pregnancy.
4) Patients with psychological conditions that contraindicate CT colonography or make them irrelevant to participate in the trial.
5) Claustrophobia.
6) Iodine hypersensitivity.
7) Severe thyroid disease.
8) Severe deafness.
9) Subjects whose eligibility for this clinical trial is not appropriate by other reasons.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichi Nagata M.D Ph.D.
Organization National Cancer Center
Division name Cancer Screening Technology Division, Research Center for Cancer Prevention and Screening
Zip code
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo 104-0045 Japan
TEL +81-3-3542-2511
Email Nagata7@aol.com

Public contact
Name of contact person
1st name
Middle name
Last name Shogo Takiguchi
Organization NTT East Izu Hospital
Division name Radiology section
Zip code
Address 750 Hirai, Kannami-cho, Tagata-gun, Shizuoka 419-0193 Japan
TEL +81-55-978-2320
Homepage URL
Email syogo@east.ntt.co.jp

Sponsor
Institute Radiology section, NTT East Izu Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor National Cancer Center
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 NTT東日本伊豆病院(静岡県)

Other administrative information
Date of disclosure of the study information
2017 Year 01 Month 25 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
2015 Year 03 Month 19 Day
Date of IRB
Anticipated trial start date
2015 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
2016 Year 07 Month 31 Day
Date trial data considered complete
Date analysis concluded
2017 Year 03 Month 31 Day

Other
Other related information Evaluation the feasibility of preserving image quality with iterative reconstruction (SAFIRE) as follows:
Group A, Low tube voltage (100kVp) in ultralow-dose CT colonography for normal weight patient; Group B, Low tube voltage (100kVp) in ultralow-dose CT colonography for overweight patient; Group C, Low tube current (20mAs) in ultralow-dose CT colonography for normal weight patient; Group D, Low tube current (20mAs) in ultralow-dose CT colonography for overweight patient.

Management information
Registered date
2017 Year 01 Month 20 Day
Last modified on
2017 Year 01 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029621

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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