Ultralow Dose Thoracic Computed Tomography in Immunocompromised Patients

NCT02755480 | Terminated

• 1 other identifier: 14-7420
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

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).

Conditions

Leukemia

Keywords

bone marrow transplant; infection; computed tomography; radiation dose

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

ultralow dose research

EXPERIMENTAL

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

Interventions

Ultralow Dose Thoracic Computed Tomography DEVICE

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

Also known as: Ultralow dose CT

ultralow dose research

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All immunocompromised patients clinically referred for LDCTT to the Medical Imaging department at PM
• years and older

You may not qualify if:

• Patients that cannot follow study procedures

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Toronto General Hospital, Department of Medical Imaging

Toronto, Ontario, M5G 2N2, Canada

Location

MeSH Terms

Conditions

Leukemia; Infections

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Narinder Paul, MD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2015
• First Posted: April 29, 2016
• Study Start: February 1, 2015
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2017
• Last Updated: October 30, 2018

Record last verified: 2018-10

Locations

CA (1)