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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000009278
Receipt No. 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

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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
Email 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
Email Nagata7@aol.com

Sponsor
Institute Kameda Medical Center
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010900

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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