Individualized Radiation Dose Control

Radiation Exposure Clinical Trial

Official title:

Individualized Radiation Dose Control: Could Neck Circumference be a New Somatometric Parameter to Adjust Tube Current for Thorax CT?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02689908
• Other study ID #: VETH123
• Status: Recruiting
• Phase: N/A
• First received: January 31, 2016
• Last updated: February 18, 2016
• Start date: May 2015
• Est. completion date: February 2016

Study information

• Verified date: February 2016
• Source: Van Military Hospital
• Contact: ferhat cuce
• Phone: +9005368515475
• Email: ferhatcuce[@]hotmail.com
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The adjustment of radiation dose in many CT protocol are based on body mass index(BMI) or weight of the patient.

In the literature, neck circumference (NC) has been reported as a new anthropometric parameter indicating the body mass for the upper body.

NC may be an important landmark in the determination of the low dose protocols for upper body CT examinations such as neck, chest and coronary CT.

Description:

Over the last few decades, MDCT(multidetector computed tomography), cardiac imaging, CT perfusion techniques, high-pitch CT, and dual-energy CT have been introduced to clinical practice, increasing the overall amount of radiation applied. There are two types of approaches in accordance with the "as low as reasonably achievable (ALARA)" principle in MDCT. One of them is related to new technology products and different imaging techniques such as dose modulation along the x-, y-, and z-axes (anatomical tube current modulation, ECG-controlled tube current modulation or dynamically adjustable pre-patient collimation of the X-ray beam in the z-axis direction, iterative reconstruction technique. The other strategy is individualized screening-dose protocols based on body size. However the radiologist is facing the challenge of providing diagnostic image quality at the lowest radiation dose.

Body mass index (BMI) is not only the most widely used anthropometric tool for defining overweight and obesity, but it is also the most commonly reported body index for adjusting low dose in MDCT.Despite this popularity of BMI, it is becoming increasingly more clear that BMI is not a good surrogate for regional adiposity. Regional fat deposition, especially in the upper body region, is a better predictor of some obesity related complications than BMI. Accordingly, it has been reported that several anthropometric parameters of the chest might serve as a surrogate instead of BMI for individualized dose settings Neck circumference(NC) is a kind of somatometric parameter like wrist or hip circumference that reflects the upper body size. NC may be an important landmark in the determination of the low dose protocols for upper body CT examinations such as neck, chest and coronary CT. Although investigators have not encountered studies in the literature, this point will be evaluated in our study.The purpose of this study is to evaluate if NC is an appropriate and a novel parameter for adjusting and reduction of the effective chest CT radiation doses in comparison with BMI or not.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• clinical diagnosis of pulmonary diseases

• participants who can be referred to radiology for diagnostic imaging

• participants who allowed to be taken somatometric measurements

Exclusion Criteria:

• participants who did not allow to be taken somatometric measurements

• participants with incomplete data (such as missing weight or height data)

• pediatric and pregnant patients

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Radiation Exposure

Intervention

Radiation:
• computed tomography
low dose protocol of thorax ct

Locations

Country	Name	City	State
Turkey	Erdem	VAN
Turkey	Ferhat	Van

Sponsors (1)

Lead Sponsor	Collaborator
Van Military Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Ghoshhajra BB, Engel LC, Major GP, Verdini D, Sidhu M, Károlyi M, Abbara S, Hoffmann U, Kalra M, Brady TJ. Direct chest area measurement: A potential anthropometric replacement for BMI to inform cardiac CT dose parameters? J Cardiovasc Comput Tomogr. 2011 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The measurement of neck circumference of the patients undergoing non-enhanced thorax CT	Before CT examination, during patient preparation, neck circumference was measured horizontally at the level of the cyricoid cartilage by a non-elastic flexible tape (centimeter, cm)	1 year	Yes
Secondary	The measurement of weight of the patients undergoing non-enhanced thorax CT	Before CT examination, during patient preparation, patient weight was measured by a bascule (kilogram, kg)	1 year	Yes
Secondary	The measurement of height of the patients undergoing non-enhanced thorax CT	Before CT examination, during patient preparation, patient height was measured with a stadiometer (milimeter, mm)	1 year	Yes
Secondary	Calculating the body mass index (BMI) using the results of each patient measured in outcome 2 and outcome 3.	calculation of data with a spesific formula (kg/mm²)	1 year	Yes

External Links

•   a similar study in the literature