Thermal Imaging to Diagnose and Monitor Suspected Bacterial Infections
Primary Purpose
Infections, Bacterial, Pneumonia, Bacterial
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FLIR ONE
Sponsored by
About this trial
This is an interventional device feasibility trial for Infections, Bacterial focused on measuring imaging, diagnostic, feasibility
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- None
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
FLIR ONE thermal camera
Arm Description
Thermal camera (FLIR ONE)
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT02292498
First Posted
November 12, 2014
Last Updated
April 28, 2017
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02292498
Brief Title
Thermal Imaging to Diagnose and Monitor Suspected Bacterial Infections
Official Title
Thermal Imaging to Diagnose and Monitor Suspected Bacterial Infections
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Bacterial, Pneumonia, Bacterial
Keywords
imaging, diagnostic, feasibility
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FLIR ONE thermal camera
Arm Type
Experimental
Arm Description
Thermal camera (FLIR ONE)
Intervention Type
Device
Intervention Name(s)
FLIR ONE
Primary Outcome Measure Information:
Title
feasibility of diagnosis of bacterial pneumonia
Description
Thermal imaging will be compared to the chest x-ray taken within 4 hours to see if bacterial pneumonia is present
Time Frame
4 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia L Hibberd, MD, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Thermal Imaging to Diagnose and Monitor Suspected Bacterial Infections
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