Ultralow Dose Thoracic Computed Tomography in Immunocompromised Patients

NCT ID: NCT02755480

Last Updated: 2018-10-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 119 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2017-02-28

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.

Conditions

Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

ultralow dose research

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.

Group Type: EXPERIMENTAL

Ultralow Dose Thoracic Computed Tomography

Intervention Type: DEVICE

Ultralow dose chest CT (uLDCTT) at a radiation dose comparable to 2 chest X-rays

Interventions

Ultralow Dose Thoracic Computed Tomography

Ultralow dose chest CT (uLDCTT) at a radiation dose comparable to 2 chest X-rays

Intervention Type: DEVICE

Other Intervention Names

Ultralow dose CT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Narinder Paul, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

Toronto General Hospital, Department of Medical Imaging

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

14-7420

Identifier Type: -

Identifier Source: org_study_id