Ultralow Dose Thoracic Computed Tomography in Immunocompromised Patients (ULDCT-IC)

October 26, 2018 updated by: University Health Network, Toronto
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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

119

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2N2
        • Toronto General Hospital, Department of Medical Imaging

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: Ultralow Dose Thoracic Computed Tomography
Ultralow dose chest CT (uLDCTT) at a radiation dose comparable to 2 chest X-rays
Other Names:
  • Ultralow dose CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Image acquisition
Time Frame: 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.
Study Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Narinder Paul, MD, University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2015

Primary Completion (Actual)

February 1, 2017

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

March 12, 2015

First Submitted That Met QC Criteria

April 25, 2016

First Posted (Estimate)

April 29, 2016

Study Record Updates

Last Update Posted (Actual)

October 30, 2018

Last Update Submitted That Met QC Criteria

October 26, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 14-7420

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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