UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009278 |
|---|---|
| Receipt number | R000010900 |
| Scientific Title | Low radiation dose screening CT colonography: evaluation the efficacy of AIDR 3D |
| Date of disclosure of the study information | 2012/11/07 |
| Last modified on | 2014/08/15 09:40:43 |
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Basic information
Public title
Low radiation dose screening CT colonography: evaluation the efficacy of AIDR 3D
Acronym
Low-dose CT colonography with AIDR 3D
Scientific Title
Low radiation dose screening CT colonography: evaluation the efficacy of AIDR 3D
Scientific Title:Acronym
Low-dose CT colonography with AIDR 3D
Region
| Japan |
Condition
Condition
Healthy individual
Classification by specialty
| Gastroenterology | Radiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation the feasibility of preserving image quality during CT colonography using low radiation dose with AIDR 3D.
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 by 2D and 3D images.
Key secondary outcomes
Radiation dose in screening CT colonography.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Dose comparison
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Low-dose CT colonography with the mild setting of the AIDR 3D algorithm.
Interventions/Control_2
Low-dose CT colonography with the standard setting of the AIDR 3D algorithm.
Interventions/Control_3
Low-dose CT colonography with the strong setting of the AIDR 3D algorithm.
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.
4) Signed informed consent forms are obtained by the patients.
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
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Nagata M.D PhD |
Organization
Kameda Medical Center
Division name
Department of Radiology
Zip code
Address
929 Higashi-cho, Kamogawa, Chiba 296-8602 Japan
TEL
047-092-2211
Nagata7@aol.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichi Nagata M.D PhD |
Organization
Kameda Medical Center
Division name
Department of Radiology
Zip code
Address
929 Higashi-cho, Kamogawa, Chiba 296-8602 Japan
TEL
047-092-2211
Homepage URL
Nagata7@aol.com
Sponsor or person
Institute
Kameda Medical Center
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
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
亀田メディカルセンター幕張（千葉県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 11 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/25097128
Number of participants that the trial has enrolled
Results
Low-dose CTC reduces radiation dose >=48.5 % compared to routine-dose CTC.
Iterative reconstruction improves overall CTC image quality compared with FBP.
Iterative reconstruction reduces overall CTC image noise compared with FBP.
Automated exposure control with iterative reconstruction is useful for low-dose CTC.
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
Main results already published
Date of protocol fixation
| 2012 | Year | 05 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 11 | Month | 06 | Day |
Last follow-up date
| 2013 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2013 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 01 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 11 | Month | 07 | Day |
Last modified on
| 2014 | Year | 08 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010900
