Radiation ExposureNCT02689908
Individualized Radiation Dose Control
A study testing computed tomography in people with Radiation Exposure, run by Van Military Hospital at 2 sites in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Radiation Exposure
- What is being tested?
- computed tomography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- May 2015to Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- clinical diagnosis of pulmonary diseases
- participants who can be referred to radiology for diagnostic imaging
- participants who allowed to be taken somatometric measurements
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites, 1 recruiting
- Completed
Ferhat
Van, Van, 65002
- Recruiting
Erdem
Van, Van
erdem cevik
About this study
Official title: Individualized Radiation Dose Control: Could Neck Circumference be a New Somatometric Parameter to Adjust Tube Current for Thorax CT?
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.
Read the detailed 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.
- Conditions
- Radiation Exposure
- Being tested
- computed tomography
- Keywords
- Thorax CT, Low Dose, Body Mass Index, Neck Circumference
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computed tomographyRadiation
low dose protocol of thorax ct
| Study group | Role | What they receive |
|---|---|---|
| The patients underwent thorax CT | Other | The patients refered to radiology service underwent thorax computed tomography without contrast material for the evaluation of various complaints such as dyspnea, hemoptysis and pulmonary infections. Receives: Radiation: computed tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 year
Secondary outcomes (3)
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)
Measured: 1 year
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)
Measured: 1 year
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)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study startMay 2015
- Primary completionFeb 2016 (estimated)
- Study completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Radiation ExposureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Van Military Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, ferhat, Van Military Hospital
- Investigators
- serkan arıbal, Principal investigator, Aksaz Military Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02689908
- Sponsor's protocol ID
- VETH123
- Status last verified
- Feb 2016
- First submitted
- 31 Jan 2016
- Last updated
- 24 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Ghoshhajra BB, Engel LC, Major GP, Verdini D, Sidhu M, Karolyi 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 Jul-Aug;5(4):240-6. doi: 10.1016/j.jcct.2011.06.003. Epub 2011 Jun 12.
PubMed 21723515
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Radiation Dose Control: Could Neck Circumference be a New Somatometric Parameter to Adjust Tube Current for Thorax CT?
- ClinicalTrials.gov ID
- NCT02689908
- Acronym / sponsor ID
- VETH123
- Conditions
- Radiation Exposure
- Keywords
- Thorax CT, Low Dose, Body Mass Index, Neck Circumference
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Van Military HospitalOther government
- Study start
- May 2015
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Feb 2016 (estimated)
- First posted
- 24 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| The patients underwent thorax CT | Other | Radiation: computed tomographyThe patients refered to radiology service underwent thorax computed tomography without contrast material for the evaluation of various complaints such as dyspnea, hemoptysis and pulmonary infections. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- clinical diagnosis of pulmonary diseases
- participants who can be referred to radiology for diagnostic imaging
- participants who allowed to be taken somatometric measurements
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| computed tomographylow dose protocol of thorax ct | Radiation | The patients underwent thorax CT |
Primary outcome
The measurement of neck circumference of the patients undergoing non-enhanced thorax CT
Time frame: 1 year
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)
3 secondary outcomes
The measurement of weight of the patients undergoing non-enhanced thorax CT
Time frame: 1 year
The measurement of height of the patients undergoing non-enhanced thorax CT
Time frame: 1 year
Calculating the body mass index (BMI) using the results of each patient measured in outcome 2 and outcome 3.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2016.
- Results publication: PubMed 21723515Ghoshhajra BB, Engel LC, Major GP, Verdini D, Sidhu M, Karolyi 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 Jul-Aug;5(4):240-6. doi: 10.1016/j.jcct.2011.06.003. Epub 2011 Jun 12.
- a similar study in the literatureLink provided by the sponsor.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
serkan arıbal principal investigator
Aksaz Military Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing computed tomography in people with Radiation Exposure, run by Van Military Hospital at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ferhat cuce (+9005368515475, ferhatcuce@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The measurement of neck circumference of the patients undergoing non-enhanced thorax CT (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02689908, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2016.