Ultralow Dose Thoracic Computed Tomography in Immunocompromised Patients

Leukemia Clinical Trial

— ULDCT-IC  

Official title:

Ultralow Dose Thoracic Computed Tomography in Immunocompromised Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02755480
• Other study ID #: 14-7420
• Status: Terminated
• Phase: N/A
• Start date: February 2015
• Est. completion date: February 2017

Study information

• Verified date: October 2018
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 119
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Leukemia

Intervention

Device:
• Ultralow Dose Thoracic Computed Tomography
Ultralow dose chest CT (uLDCTT) at a radiation dose comparable to 2 chest X-rays

Locations

Country	Name	City	State
Canada	Toronto General Hospital, Department of Medical Imaging	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Image acquisition	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.	Study Day 1