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

NCT ID: NCT02275143

Last Updated: 2016-05-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2016-02-29

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

CT TAP scan

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

CT TAP Scan

Intervention Type: 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.

Interventions

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.

Intervention Type: RADIATION

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Plymouth NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Carl Roobottom, MBChB FRCP

Role: STUDY_DIRECTOR

University Hospital Plymouth NHS Trust

Locations

Plymouth Hospitals NHS Trust (PHNT)

Plymouth, Devon, United Kingdom

Countries

United Kingdom

Other Identifiers

14/P/152

Identifier Type: -

Identifier Source: org_study_id