- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02275143
Computed Tomography (CT) Coronary Angiogram Evaluation in Cancer Patients Having CT Thorax, Abdomen and Pelvis
May 23, 2016 updated by: University Hospital Plymouth NHS Trust
Feasibility of Computed Tomography (CT) Coronary Angiogram Evaluation in Cancer Patients Having CT Thorax, Abdomen and Pelvis (CT TAP)
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.
Study Overview
Detailed Description
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.
Study Type
Observational
Enrollment (Actual)
80
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Devon
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Plymouth, Devon, United Kingdom, PL6 8DH
- Plymouth Hospitals NHS Trust (PHNT)
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients having routine follow up cancer CT TAP scan
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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CT TAP scan
Suitable patients will be identified after consultant radiologists have approved a request for cancer routine CT TAP scan.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective Image quality analysis
Time Frame: 20 minutes
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Calculating image noise as measured by standard deviation (SD) in a region of interest.
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20 minutes
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Objective Image quality analysis
Time Frame: 20 minutes
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Calculating contrast-to-noise ratio (CNR)
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20 minutes
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Subjective Image quality analysis
Time Frame: 20 minutes
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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.
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20 minutes
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dose estimation
Time Frame: 20 minutes
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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).
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20 minutes
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Coronary segments analysis
Time Frame: 20minutes
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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.
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20minutes
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Carl Roobottom, MBChB FRCP, University Hospital Plymouth NHS Trust
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2015
Primary Completion (Actual)
February 1, 2016
Study Completion (Actual)
February 1, 2016
Study Registration Dates
First Submitted
October 23, 2014
First Submitted That Met QC Criteria
October 24, 2014
First Posted (Estimate)
October 27, 2014
Study Record Updates
Last Update Posted (Estimate)
May 24, 2016
Last Update Submitted That Met QC Criteria
May 23, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14/P/152
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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