UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Dose reduction and image quality in low tube voltage CT colonography: evaluation the efficacy of SAFIRE
Title of the study (Brief title)	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	Koichi Nagata M.D Ph.D.
Organization	National Cancer Center
Division name	Cancer Screening Technology Division, Research Center for Cancer Prevention and Screening
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	Shogo Takiguchi
Organization	NTT East Izu Hospital
Division name	Radiology section
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2015 Year 03 Month 19 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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