Fully Automated Scan Technique Optimisation of Scan Timing in Chest CT

NCT03658200 | Terminated DMC

• 1 other identifier: NL63106.068.17
• Study Type: interventional
• Target: 223
• Locations: 1 country
• Sites: 1

Brief Summary

Computed Tomography Angiography (CTA) is a non-invasive imaging tool widely used for various indications. Contrast media (CM) is used to enhance the intravascular lumen and organ parenchyma, depending on the indication. Recent technical advances in CT scan techniques allow for a very fast scan acquisition with substantially increased image quality in terms of temporal and spatial resolution. However, with faster scan acquisition, challenges arise with regard to CM bolus timing. The risk of outrunning the CM bolus in these fast acquisitions is higher, resulting in a decreased intravascular attenuation and subsequent hypothetical increase in non-diagnostic image quality. Previous studies have investigated the reduction of CM volume. When reducing the CM volume, the total injection time decreases and the window of peak enhancement shortens and becomes more narrow. The latter increases when injecting small CM volumes with higher flow rates. Although the peak enhancement increases, the window of peak enhancement decreases more rapidly. Thus, when administered with the same flow rate, the peak of the enhancement curve will be lower, narrower and faster compared to larger CM volumes. This, in combination with the faster scan acquisition makes the timing of the start of the scan highly important, since scanning at the peak enhancement is necessary to achieve a diagnostic image quality. New bolus tracking auto-delay software (Fully Automated Scan Technique, FAST, Siemens Healthineers) automatically estimates the delay needed to scan at the peak of the enhancement curve. With help of this software, the optimal individual scan delay and enhancement can be achieved, and the risk of non-diagnostic scans should decrease. Therefore, this study aims to evaluate the performance of the Bolus Tracking Auto-Delay (FAST) software in patients receiving a standard chest CT with regard to the number of non-diagnostic scans (\< 300 HU) and compare this with standard care (manual set pre-scan delay).

Conditions

Pulmonary Disease

Keywords

Chest CT; Bolus tracking; Image quality; Contrast media

Outcome Measures

Primary Outcomes (1)

• Intravascular enhancement

  To evaluate the performance of the FAST software in patients receiving a thoracic CTA with regard to the number of non-diagnostic scans (\< 300 HU) in comparison with standard care (manual scan delay).

  2 years

Secondary Outcomes (6)

• Enhancement curves

  2 years

• Intravascular attenuation

  2 years

• Image noise

  2 years

• Signal-to-noise

  2 years

• Contrast-to-noise

  2 years

Study Arms (2)

FAST software

ACTIVE COMPARATOR

Patient referred for chest CT and scanned with delay based on bolus tracking with FAST software. intervention: FAST START Software delay

Other: FAST start software delay

Control

ACTIVE COMPARATOR

Patient referred for chest CT and scanned with delay based on bolus tracking without FAST software. Intervention: Manual bolus tracking delay

Other: Manual bolus tracking delay

Interventions

FAST start software delay OTHER

Scan delay will be determined by the FAST software bolus tracking technique. Before the start of bolus tracking (the time between start injection and start bolus tracking), a delay of 8 s is chosen. Bolus tracking threshold is set at 100 HU with a cycle time of 1.13 s and scan time of 0.25 s. After reaching the 100 HU threshold the FAST START software calculates the delay.

FAST software

Manual bolus tracking delay OTHER

Scan delay will be determined by the standard bolus tracking technique. Before the start of bolus tracking (the time between start injection and start bolus tracking), a delay of 8 s is chosen. Bolus tracking threshold is set at 100 HU with a cycle time of 1.13 s and scan time of 0.25 s. After reaching the 100 HU threshold a delay of 6 s is chosen (table movement and breath hold command) and the scan starts.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients referred for standard chest CT
• Patients older than 18 years and competent to give informed consent

You may not qualify if:

• Hemodynamic instability;
• Pregnancy;
• Renal insufficiency (defined as Glomerular Filtration Rate (GFR) \< 30 mL/min (Odin protocol 004720));
• Iodine allergy;
• Age \<18 years;
• Absence of informed consent

Sponsors & Collaborators

• Maastricht University Medical Center: lead

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6202 AZ, Netherlands

Location

Related Publications (7)

• Bae KT. Intravenous contrast medium administration and scan timing at CT: considerations and approaches. Radiology. 2010 Jul;256(1):32-61. doi: 10.1148/radiol.10090908.

  PMID: 20574084 BACKGROUND

• Funama Y, Awai K, Nakayama Y, Kakei K, Nagasue N, Shimamura M, Sato N, Sultana S, Morishita S, Yamashita Y. Radiation dose reduction without degradation of low-contrast detectability at abdominal multisection CT with a low-tube voltage technique: phantom study. Radiology. 2005 Dec;237(3):905-10. doi: 10.1148/radiol.2373041643. Epub 2005 Oct 19.

  PMID: 16237139 BACKGROUND

• Huda W, Scalzetti EM, Levin G. Technique factors and image quality as functions of patient weight at abdominal CT. Radiology. 2000 Nov;217(2):430-5. doi: 10.1148/radiology.217.2.r00nv35430.

  PMID: 11058640 BACKGROUND

• Nakayama Y, Awai K, Funama Y, Hatemura M, Imuta M, Nakaura T, Ryu D, Morishita S, Sultana S, Sato N, Yamashita Y. Abdominal CT with low tube voltage: preliminary observations about radiation dose, contrast enhancement, image quality, and noise. Radiology. 2005 Dec;237(3):945-51. doi: 10.1148/radiol.2373041655. Epub 2005 Oct 19.

  PMID: 16237140 BACKGROUND

• Kok M, Mihl C, Hendriks BM, Altintas S, Kietselaer BL, Wildberger JE, Das M. Optimizing contrast media application in coronary CT angiography at lower tube voltage: Evaluation in a circulation phantom and sixty patients. Eur J Radiol. 2016 Jun;85(6):1068-74. doi: 10.1016/j.ejrad.2016.03.022. Epub 2016 Mar 22.

  PMID: 27161054 BACKGROUND

• Kok M, Mihl C, Seehofnerova A, Turek J, Jost G, Pietsch H, Haberland U, Wildberger JE, Das M. Automated Tube Voltage Selection for Radiation Dose Reduction in CT Angiography Using Different Contrast Media Concentrations and a Constant Iodine Delivery Rate. AJR Am J Roentgenol. 2015 Dec;205(6):1332-8. doi: 10.2214/AJR.14.13957.

  PMID: 26587942 BACKGROUND

• Korporaal JG, Bischoff B, Arnoldi E, Sommer WH, Flohr TG, Schmidt B. Evaluation of A New Bolus Tracking-Based Algorithm for Predicting A Patient-Specific Time of Arterial Peak Enhancement in Computed Tomography Angiography. Invest Radiol. 2015 Aug;50(8):531-8. doi: 10.1097/RLI.0000000000000160.

  PMID: 25900084 BACKGROUND

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

• Joachim E Wildberger, Prof.

  Maastricht University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. J.E. Wildberger

Study Record Dates

• First Submitted: April 25, 2018
• First Posted: September 5, 2018
• Study Start: April 5, 2018
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: March 21, 2019

Record last verified: 2019-03

Locations

NL (1)