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NCT Number: NCT02275143

Computed Tomography (CT) Coronary Angiogram Evaluation in Cancer Patients Having CT Thorax, Abdomen and Pelvis

Currently patients with certain cancer usually have routine follow up (Computed Tomography of Thorax, Abdomen and Pelvis) CT TAP scans to see response to treatment or relapse. The study proposal allows the evaluation of the coronary arteries by modifying the current CT TAP technique without significant additional procedures, intravenous contrast or radiation - i.e. an opportunistic Computed Tomography Coronary Angiogram (CTCA) without any penalty. The question is does performing Computed Tomography (CT) of the thorax in such a way confer important additional information about cardiac risk? At the same time the investigators need to ensure that doing scan as per CTCA protocol produces equivalent image quality to evaluate other structures in the chest. A recent small retrospective study has using a similar technique suggests that it may in fact improve image quality due to less cardiac related motion artefact.

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Key information

Conditions

Coronary Stenosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Plymouth Hospitals NHS Trust (PHNT)

Plymouth, Devon, PL6 8DH, United Kingdom

About this study

The study is a non-inferiority observational study to primarily ensure that the Computed Tomography of Thorax, Abdomen and Pelvis (CT TAP) technique produces equivalent image quality of the lungs (hence the need to scan with both conventional technique and the Electrocardiograph [ECG] gated technique) and secondarily to evaluate the effectiveness of demonstrating the coronary arteries in this cohort of patients who have not received heart rate control.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients having routine follow up cancer CT TAP scan
  • Age more than or equal to 40 years of age at the time of scan.
  • Able to provide informed written consent
  • Able to hold their breath for at least 10 seconds
  • Has regular heart rate
  • Able to follow verbal commands for breath holding and remain still for the duration of scanning
  • Able to lie supine for the entirety of the scan

Exclusion criteria

  • Patient unable to give informed consent.
  • Patients unable to lie supine
  • Patient not able to breath hold for at least 10 seconds.
  • Patients not having regular heart rate. Patient with atrial fibrillation or >2 atrial or ventricular premature beats on a preoperative 12 lead ECG (suboptimal image quality results from irregular heart rhythms)
  • Patient having eGFR <30, to avoid risk of contrast nephrotoxicity in patients potentially at risk) or chronic renal failure on dialysis
  • Patient has known contrast reaction.
  • Patient is pregnant.
  • Patients BMI>35
  • Unavailability of research slot to accommodate for the urgency of the scan requested.

Treatment and study plan

CT TAP Scan

Radiation

Modification of chest CT protocol in the routine CT TAP: The Research CT of Thorax will be acquired as per the routinely performed CTCA with inclusion of the lung apices. Therefore the study will be acquired axially with prospective gating.

Primary outcomes

  1. Objective Image quality analysis

    Time frame: 20 minutes

    Calculating image noise as measured by standard deviation (SD) in a region of interest.

  2. Objective Image quality analysis

    Time frame: 20 minutes

    Calculating contrast-to-noise ratio (CNR)

  3. Subjective Image quality analysis

    Time frame: 20 minutes

    All image data sets will be presented in blinded and randomized manner to two experienced consultant radiologists. Subjective image quality will be assessed in terms of subjective image noise, subjective image contrast, lesion conspicuity, diagnostic confidence and artefacts. The image quality attributes are taken from the European Guidelines on Quality Criteria for Computerized Tomography document and have been proven to be robust in comparing subjective image quality.

Secondary outcomes

  1. Dose estimation

    Time frame: 20 minutes

    The total exam dose-length product (DLP) displayed by the CT scanner at the end of each CTPA is recorded. The effective dose in mSv is calculated by multiplying the total DLP for each exam by the conversion coefficient for the chest of 0.014 (as taken from National Radiological Protection Board Document).

  2. Coronary segments analysis

    Time frame: 20minutes

    Image quality of the 4 main coronary arteries (left main, left anterior descending, left circumflex, and right coronary artery) was determined based on a 4-point grading system - Non-diagnostic; Adequate; Good; Excellent.

Sponsors and collaborators

Lead sponsor

University Hospital Plymouth NHS Trust

Other

Registry information

Official study title

Feasibility of Computed Tomography (CT) Coronary Angiogram Evaluation in Cancer Patients Having CT Thorax, Abdomen and Pelvis (CT TAP)

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Oct 27, 2014
Registry last updated
May 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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