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

Coronary Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02275143
• Other study ID #: 14/P/152
• Status: Completed
• Phase: N/A
• First received: October 23, 2014
• Last updated: May 23, 2016
• Start date: October 2015
• Est. completion date: February 2016

Study information

• Verified date: May 2016
• Source: Plymouth Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeUnited Kingdom: National Health Service
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Stenosis

Intervention

Radiation:
• CT TAP Scan
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.

Locations

Country	Name	City	State
United Kingdom	Plymouth Hospitals NHS Trust (PHNT)	Plymouth	Devon

Sponsors (1)

Lead Sponsor	Collaborator
Plymouth Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective Image quality analysis	Calculating image noise as measured by standard deviation (SD) in a region of interest.	20 minutes	No
Primary	Objective Image quality analysis	Calculating contrast-to-noise ratio (CNR)	20 minutes	No
Primary	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.	20 minutes	No
Secondary	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).	20 minutes	No
Secondary	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.	20minutes	No