- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02292498
Thermal Imaging to Diagnose and Monitor Suspected Bacterial Infections
April 28, 2017 updated by: Patricia L. Hibberd, Massachusetts General Hospital
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: FLIR ONE thermal camera
Thermal camera (FLIR ONE)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
feasibility of diagnosis of bacterial pneumonia
Time Frame: 4 hours
|
Thermal imaging will be compared to the chest x-ray taken within 4 hours to see if bacterial pneumonia is present
|
4 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Patricia L Hibberd, MD, PhD, Massachusetts General Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2014
Primary Completion (Actual)
June 1, 2016
Study Completion (Actual)
June 1, 2016
Study Registration Dates
First Submitted
November 12, 2014
First Submitted That Met QC Criteria
November 14, 2014
First Posted (Estimate)
November 17, 2014
Study Record Updates
Last Update Posted (Actual)
May 3, 2017
Last Update Submitted That Met QC Criteria
April 28, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014P001327
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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