UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025762 |
|---|---|
| Receipt number | 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 17:02:06 |
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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
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
syogo@east.ntt.co.jp
Sponsor or person
Institute
Radiology section, NTT East Izu Hospital
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
National Cancer Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029621
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
