Ultralow Dose Thoracic Computed Tomography in Immunocompromised Patients

Not Applicable

Terminated

• Conditions: Leukemia
• Interventions: Device: Ultralow Dose Thoracic Computed Tomography

• Registration Number: NCT02755480
• Lead Sponsor: University Health Network, Toronto

Brief Summary

Patients with bone marrow cancer are more susceptible to chest infections than healthy adults; marrow ablation treatment further compromises their immune status and increases the risk of fungal opportunistic infection, which is associated with a high fatality rate. Therefore, it is critical to achieve early and accurate diagnosis of fungal infection when these patients become febrile. At the Mount Sinai Hospital (MSH) and the University Health Network (UHN), the standard of care (SOC) to exclude a chest infection in immunocompromised (IC) patients is chest computed tomography (CT) using low dose CT (LDCTT).

Detailed Description

As patients may have several febrile episodes during their hospital stay, the cumulative dose from LDCTT scans can be significant and increase the lifetime risk of inducing a second cancer. The aim of this project is to determine whether a 75% reduction in radiation dose for LDCTT in other words, an ultralow dose chest CT (uLDCTT) at a dose comparable to chest X-ray, maintains the diagnostic image quality for detection of fungal chest infection in IC patients. If successful, uLDCTT will be adopted as SOC imaging at Princess Margaret Cancer Center (PM) for these patients.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-03-12
• Study First Submitted QC: 2016-04-25
• Study First Posted: 2016-04-29
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-26
• Last Update Posted: 2018-10-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 119

Inclusion Criteria

1. All immunocompromised patients clinically referred for LDCTT to the Medical Imaging department at PM
2. 18 years and older

Exclusion Criteria

1. Patients that cannot follow study procedures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ultralow dose research	Ultralow Dose Thoracic Computed Tomography	An Ultralow Dose Thoracic Computed Tomography scan will be added to the standard of care Low dose CT scan. The image quality of the ultralow dose CT will be compared to the Low dose thoracic Computed Tomography.

Primary Outcome Measures

Name	Time	Method
Image acquisition	Study Day 1	Perform paired clinical low dose (LDCTT) and research ultralow dose (uLDCTT) chest CT in immunocompromised (IC) patients who present with febrile neutropenia (FN) and are clinically referred for LDCTT to exclude opportunistic fungal infection.

Trial Locations

Locations (1)

Toronto General Hospital, Department of Medical Imaging; 🇨🇦 Toronto, Ontario, Canada