NCT02292498

Brief Summary

The purpose of this study is to test the feasibility of using thermal images to diagnose bacterial pneumonia instead of a chest x-ray in the future. More specifically, the objectives of this study are: 1) to determine if thermal imaging, using a commercial thermal camera can detect areas of heat emitted from the chest in similar locations to where a chest X-ray shows focal consolidation consistent with bacterial pneumonia; 2) to evaluate whether changes in heat emitted from the chest changes over time if it is possible to obtain serial images of the chest.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

1 active site

Status
completed

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

November 1, 2014

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

November 12, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 17, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

May 3, 2017

Status Verified

April 1, 2017

Enrollment Period

1.6 years

First QC Date

November 12, 2014

Last Update Submit

April 28, 2017

Conditions

Infections, BacterialPneumonia, Bacterial

Keywords

imaging, diagnosticfeasibility

Outcome Measures

Primary Outcomes (1)

  • feasibility of diagnosis of bacterial pneumonia

    Thermal imaging will be compared to the chest x-ray taken within 4 hours to see if bacterial pneumonia is present

    4 hours

Study Arms (1)

FLIR ONE thermal camera

EXPERIMENTAL

Thermal camera (FLIR ONE)

Device: FLIR ONE

Interventions

FLIR ONEDEVICE
FLIR ONE thermal camera

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subject sent for a clinical chest X-ray (not research) to rule out pneumonia
  • Thermal images obtained using FLIR ONE within 4 hours of the chest x-ray
  • Signed informed consent obtained
  • Subject is a patient at a participating clinic at Massachusetts General Hospital

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Bacterial InfectionsPneumonia, BacterialDisease

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfectionsPneumoniaRespiratory Tract InfectionsLung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Patricia L Hibberd, MD, PhD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Division of Pediatric Global Health

Study Record Dates

First Submitted

November 12, 2014

First Posted

November 17, 2014

Study Start

November 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

May 3, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)