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

NCT02275143 | Completed

• 1 other identifier: 14/P/152
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Stenosis

Keywords

Computed Tomography of Thorax, Abdomen and Pelvis; cancer patients; coronary angiogram evaluation

Outcome Measures

Primary Outcomes (3)

• Objective Image quality analysis

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

  20 minutes

• Objective Image quality analysis

  Calculating contrast-to-noise ratio (CNR)

  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.

  20 minutes

Secondary Outcomes (2)

• Dose estimation

  20 minutes

• Coronary segments analysis

  20minutes

Study Arms (1)

CT TAP scan

Suitable patients will be identified after consultant radiologists have approved a request for cancer routine CT TAP scan.

Radiation: CT TAP Scan

Interventions

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.

CT TAP scan

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients having routine follow up cancer CT TAP scan

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital Plymouth NHS Trust: lead

Study Sites (1)

Plymouth Hospitals NHS Trust (PHNT)

Plymouth, Devon, PL6 8DH, United Kingdom

Location

MeSH Terms

Conditions

Coronary Stenosis

Condition Hierarchy (Ancestors)

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

Study Officials

• Carl Roobottom, MBChB FRCP

  University Hospital Plymouth NHS Trust

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2014
• First Posted: October 27, 2014
• Study Start: October 1, 2015
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: May 24, 2016

Record last verified: 2016-05

Locations

GB (1)