Coronary StenosisNCT02275143
Computed Tomography (CT) Coronary Angiogram Evaluation in Cancer Patients Having CT Thorax, Abdomen and Pelvis
An observational study of Coronary Stenosis, run by University Hospital Plymouth NHS Trust at 1 site in United Kingdom.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Coronary Stenosis
- What is being tested?
- CT TAP Scan
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2015to Feb 2016
- Phase
- Observational
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients having routine follow up cancer CT TAP scan
Who may be able to join
- 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
Who cannot join
- 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.
Show all 9Show fewer
- Patient is pregnant.
- Patients BMI>35
- Unavailability of research slot to accommodate for the urgency of the scan requested.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Plymouth Hospitals NHS Trust (PHNT)
Plymouth, Devon, PL6 8DH
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronary Stenosis
- Being tested
- CT TAP Scan
- Keywords
- Computed Tomography of Thorax, Abdomen and Pelvis, cancer patients, coronary angiogram evaluation
- Medical subject headings
- Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT TAP ScanRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| CT TAP scan | Suitable patients will be identified after consultant radiologists have approved a request for cancer routine CT TAP scan. Receives: Radiation: CT TAP Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Image quality analysis
Calculating image noise as measured by standard deviation (SD) in a region of interest.
Measured: 20 minutes
Objective Image quality analysis
Calculating contrast-to-noise ratio (CNR)
Measured: 20 minutes
Subjective Image quality analysis
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.
Measured: 20 minutes
Secondary outcomes (2)
Dose estimation
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).
Measured: 20 minutes
Coronary segments analysis
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.
Measured: 20minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2014 (estimated)
- Study startOct 2015
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary StenosisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Plymouth NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carl Roobottom, MBChB FRCP, Study director, University Hospital Plymouth NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02275143
- Sponsor's protocol ID
- 14/P/152
- Status last verified
- May 2016
- First submitted
- 23 Oct 2014
- Last updated
- 24 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Computed Tomography (CT) Coronary Angiogram Evaluation in Cancer Patients Having CT Thorax, Abdomen and Pelvis (CT TAP)
- ClinicalTrials.gov ID
- NCT02275143
- Acronym / sponsor ID
- 14/P/152
- Conditions
- Coronary Stenosis
- Keywords
- Computed Tomography of Thorax, Abdomen and Pelvis, cancer patients, coronary angiogram evaluation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital Plymouth NHS TrustUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 27 Oct 2014 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CT TAP scan | – | Radiation: CT TAP ScanSuitable patients will be identified after consultant radiologists have approved a request for cancer routine CT TAP scan. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients having routine follow up cancer CT TAP scan
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| CT TAP ScanModification 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. | Radiation | CT TAP scan |
Primary outcome
Objective Image quality analysis
Time frame: 20 minutes
Calculating image noise as measured by standard deviation (SD) in a region of interest.
Objective Image quality analysis
Time frame: 20 minutes
Calculating contrast-to-noise ratio (CNR)
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.
2 secondary outcomes
Dose estimation
Time frame: 20 minutes
Coronary segments analysis
Time frame: 20minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2016.
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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.
Carl Roobottom, MBChB FRCP study director
University Hospital Plymouth NHS Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Stenosis, run by University Hospital Plymouth NHS Trust at 1 site in United Kingdom.
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 7 inclusion and 9 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: finished, as of the sponsor's last update on 24 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Image quality analysis (time frame: 20 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 May 2016.