NCT02391896

Brief Summary

Computed tomography (CT) is the most accurate test for evaluating patients with thoracic disease. However, access to CT is limited due to long wait times and for the sickest patients in Hospital who cannot be transported from the ward to the CT scanner. The investigators propose to modify a standard X-ray unit to provide more detailed information of the chest such that a CT scan is not required for all patients.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 18, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

October 25, 2018

Status Verified

October 1, 2018

Enrollment Period

1.8 years

First QC Date

March 12, 2015

Last Update Submit

October 23, 2018

Conditions

Thoracic Diseases

Outcome Measures

Primary Outcomes (1)

  • Improved detection of maliganancy with modified x-ray

    6 months

Study Arms (2)

Digital Tomosynthesis

OTHER

Patient will get tomosynthesis scan

Device: Dual energy and tomosynthesis xray

Dual energy

OTHER

Patient will get dual energy scan

Device: Dual energy and tomosynthesis xray

Interventions

Dual energy and tomosynthesis xrayDEVICE
Digital TomosynthesisDual energy

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • the presence of lung disease (nodules, masses, consolidation and collapse), pleural disease (effusion, thickening), mediastinal and hilar lymph node enlargement, on thoracic CT

You may not qualify if:

  • unable to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Toronto General Hospital, Department of Medical Imaging

Toronto, Ontario, M5G 2N2, Canada

Location

MeSH Terms

Conditions

Thoracic Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • Narinder Paul, MD

    UHN

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2015

First Posted

March 18, 2015

Study Start

March 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

October 25, 2018

Record last verified: 2018-10

Locations

CA(1)