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临床试验/CTRI/2018/12/016618
CTRI/2018/12/016618招募中1/2 期

Establishing Diagnostic Reference level and optimization of radiation dose for Computed Tomography of head in Pediatric Population

NA1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2018年12月17日最近更新:

试验速览

阶段
1/2 期
状态
招募中
发起方
NA
入组人数
250
试验地点
1
主要终点
CTDI vol (mGy)

研究概览

简要总结

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.

研究设计

研究类型
Observational

入排标准

年龄范围
0.00 Year(s) 至 5.00 Year(s)(—)
性别
All

入选标准

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

排除标准

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

结局指标

主要结局

CTDI vol (mGy)

时间窗: 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

时间窗: 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)

时间窗: 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)

时间窗: 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

次要结局

  • Subjective and Objective image quality Assessment

研究者

发起方
NA
申办方类型
Other []

研究点 (1)

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