LeukemiaULDCT-ICNCT02755480
Ultralow Dose Thoracic Computed Tomography in Immunocompromised Patients
A study testing Ultralow Dose Thoracic Computed Tomography in people with Leukemia, run by University Health Network, Toronto at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Leukemia
- What is being tested?
- Ultralow Dose Thoracic Computed Tomography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2015to Feb 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All immunocompromised patients clinically referred for LDCTT to the Medical Imaging department at PM
- 18 years and older
Who cannot join
- Patients that cannot follow study procedures
Trial locations and contacts
1 site in 1 country.
Canada1 site
Toronto General Hospital, Department of Medical Imaging
Toronto, Ontario, M5G 2N2
About this study
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).
Read the 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
- Being tested
- Ultralow Dose Thoracic Computed Tomography
- Keywords
- bone marrow transplant, infection, computed tomography, radiation dose
- Medical subject headings
- Leukemia, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultralow Dose Thoracic Computed TomographyDevice
Also called Ultralow dose CT
Ultralow dose chest CT (uLDCTT) at a radiation dose comparable to 2 chest X-rays
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Ultralow Dose Thoracic Computed Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Study Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study startFeb 2015
- Primary completionFeb 2017
- Study completionFeb 2017
Why it stopped: PI has left UHN. This study is no longer running at UHN.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Narinder Paul, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02755480
- Sponsor's protocol ID
- 14-7420
- Acronym
- ULDCT-IC
- Status last verified
- Oct 2018
- First submitted
- 12 Mar 2015
- Last updated
- 30 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultralow Dose Thoracic Computed Tomography in Immunocompromised Patients
- ClinicalTrials.gov ID
- NCT02755480
- Acronym / sponsor ID
- ULDCT-IC / 14-7420
- Conditions
- Leukemia
- Keywords
- bone marrow transplant, infection, computed tomography, radiation dose
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI has left UHN. This study is no longer running at UHN.
- Enrolment
- 119 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 29 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ultralow dose research | Experimental | Device: Ultralow Dose Thoracic Computed TomographyAn 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All immunocompromised patients clinically referred for LDCTT to the Medical Imaging department at PM
- 18 years and older
Key exclusion criteria (1 listed)
- Patients that cannot follow study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultralow Dose Thoracic Computed TomographyAlso: Ultralow dose CTUltralow dose chest CT (uLDCTT) at a radiation dose comparable to 2 chest X-rays | Device | ultralow dose research |
Primary outcome
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.
Results and safety
The study was stopped early (reason given: PI has left UHN. This study is no longer running at UHN.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Narinder Paul, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultralow Dose Thoracic Computed Tomography in people with Leukemia, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 30 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: PI has left UHN. This study is no longer running at UHN.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Image acquisition (time frame: Study Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2018.