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Quality of the CT brain images at low radiation exposure compared to high radiation exposure among the patients who are indicated for non-contrast CT brain scan: A Non-inferiority Randomized single blind control trial

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SLCTR Registration Number

SLCTR/2019/004


Date of Registration

01 Feb 2019

The date of last modification

Aug 24, 2019


View original TRDS


Trial Status



Application Summary


Scientific Title of Trial

Quality of the CT brain images at low radiation exposure compared to high radiation exposure among the patients who are indicated for non-contrast CT brain scan: A Non-inferiority Randomized single blind control trial


Public Title of Trial

Quality of the CT brain images at low radiation exposure compared to high radiation exposure.


Disease or Health Condition(s) Studied

Brain imaging


Scientific Acronym

None


Public Acronym

None


Brief title

Quality of the CT brain images at low radiation exposure compared to high radiation exposure among the patients


Universal Trial Number

None


Any other number(s) assigned to the trial and issuing authority

P/122/06/2018 - Ethics Review Committee, Faculty of Medicine, University of Kelaniya


Trial Details


What is the research question being addressed?

Are the quality of the CT brain images at low radiation exposure inferior to those with high radiation exposure?


Type of study

Interventional


Study design

Allocation

Randomized controlled trial


Masking

Single blinded


Control

Standard therapy/practice


Assignment

Parallel


Purpose

Diagnostic


Study Phase

Not Applicable


Intervention(s) planned

Study setting Department of Radiology- CNTH-Ragama.

All eligible patients will be randomized to the intervention or control group using computer generated random numbers.

Intervention group patients will be exposed to tube current value of 130 milliamperes (Ma).

Control group will be exposed to manufacturer set default tube current value of 300 milliamperes (Ma) which is practiced currently.

A radiographer will carry out the CT examinations in control and study groups. Helical CT will be performed parallel to cantho-meatal line from skull base to vertex. Hard copy CT films will be printed for each patient to use image quality analysis.

Outcome assessors will be blinded to the intervention.


Inclusion criteria

• Patients of 18 years and above • Men and women • Patients who are sent the Radiology department for routine non contrast CT brain (Both traumatic and non traumatic).


Exclusion criteria

• Pregnant Patients

• Critically ill patients

• Unconscious patients

• Patients who are not able to provide information.



Primary outcome(s)

1.

Assessment of image quality in study group and control using European guide lines for quality criteria for CT http://www.drs.dk/guidelines/ct/quality/htmlindex.htm

[

During routing CT reporting

]

Secondary outcome(s)

1.

None

[

N/A

]

Target number/sample size

166 for each group.


Countries of recruitment

Sri Lanka


Anticipated start date

2019-02-01


Anticipated end date

2019-04-30


Date of first enrollment


Date of study completion


Recruitment status

Recruiting


Funding source

None


Regulatory approvals



State of Ethics Review Approval


Status

Approved


Date of Approval

2018-09-11


Approval number

P/122/06/2018


Details of Ethics Review Committee

Name: Ethics Review Committee, Faculty of Medicine, University of Kelaniya
Institutional Address:PO Box 6, Thalagolla Road, Ragama Sri Lanka
Telephone:+94-11-2961267
Email: erckelaniya@gmail.com

Contact & Sponsor Information


Contact person for Scientific Queries/Principal Investigator

Dr.C.Sirigampala
Consultant Radiologist.
Colombo North Teaching Hospital - Ragama
0112959261
0773772410

chandrasirigampala@gmail.com

Contact Person for Public Queries

Dr.C.Sirigampala
Consultant Radiologist.
Colombo North Teaching Hospital - Ragama
0112959261
0773772410

chandrasirigampala@gmail.com


Primary study sponsor/organization

Colombo North Teaching Hospital Ragama

Ragama, Sri Lanka
0112959261


Secondary study sponsor (If any)

None





Trial Completion details


Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?

Yes


IPD sharing plan description

Individual participant data that underlie the results will be shared after the de-identification (tables,figures,appendices). The study protocol will also be available. This will be immediately following publication (no end date). Data sharing will be with investigators whose proposed use of the data has been approved by an independent review committee/ethical review committee identified for this purpose. Data will be made available for IPD meta analysis.


Study protocol available


Protocol version and date

Not Available


Protocol URL

Not Available


Results summary available

No


Date of posting results


Date of study completion


Final sample size


Date of first publication


Link to results


Brief summary of results