Establishing diagnostic reference level ofradiation dose and using low dose protocol for CT head in pediatric population

Phase 1/2

Recruiting

• Conditions: Other specified disorders of brain,

• Registration Number: CTRI/2018/12/016618
• Lead Sponsor: NA

Brief Summary

The study is a cross sectional observational study and  will be done in two phase. 

Phase 1: Include 143 patients.Scanning will be performed using standard pediatric brain protocol. Dose info such as CTDI vol  and DLP will be noted at the end of the scan and effective dose will be calculated from DLP. The 3rd quartile value of CTDI vol and DLP will be calculated to establish Diagnostic Reference Levels.



Phase2: Scanning will be performed using low dose pediatric brain protocol. Dose info such as CTDI vol  and DLP will be noted at the end of the scan and effective dose will be calculated from DLP. Subjective and objective assessment  of image quality will be done. The 3rd quartile value of CTDI vol and DLP will be calculated to establish Diagnostic Reference Levels for low dose.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-17
• Last Update Posted: 2020-04-02

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 250

Inclusion Criteria

Pediatric patients referred for CT head with age range of 0- 5 years.

Exclusion Criteria

Pediatric patients referred for Contrast enhanced CT brain and Un co-operative patients.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
CTDI vol (mGy)	CTDIvol and DLP- will be noted at the end of each scan | Effective dose (mSv) will be calculated from DLP | CTDIvol and DLP will be used to calculate DRL
DRL- Diagnostic Reference Level	CTDIvol and DLP- will be noted at the end of each scan | Effective dose (mSv) will be calculated from DLP | CTDIvol and DLP will be used to calculate DRL
DLP- Dose Length Product (mGy.cm)	CTDIvol and DLP- will be noted at the end of each scan | Effective dose (mSv) will be calculated from DLP | CTDIvol and DLP will be used to calculate DRL
Effective dose (mSv)	CTDIvol and DLP- will be noted at the end of each scan | Effective dose (mSv) will be calculated from DLP | CTDIvol and DLP will be used to calculate DRL

Secondary Outcome Measures

Name	Time	Method
Subjective and Objective image quality Assessment

Trial Locations

Locations (1)

Kasturba Medical College and Hospital,Manipal; 🇮🇳 Udupi, KARNATAKA, India

Kasturba Medical College and Hospital,Manipal

🇮🇳Udupi, KARNATAKA, India

Priyanka

Principal investigator

9739314908

priyanka.rao@manipal.edu