Thermographic Characteristics of Sore Throat by Thermographic Camera (thermography)

January 26, 2016 updated by: Doron Carmi
Thermographic cameras are used to determine temperature and temperature differences. Attempts have been made to use the thermographic camera as a diagnostic tool in clinical practice. Thermographic cameras have been approved by the FDA in the diagnosis of breast cancer. The camera absorbs infrared radiation which is discharged from the tissue and than translates it to a digital data or a photograph. The camera does not radiate and direct contact with the patient is not needed. The safety is similar to a regular optic camera. No study on thermographic characteristics of inflammation of organs has been published. The purpose of this study is to demonstrate and document these characteristics of inflammation. The correlation between the thermographic imaging and the clinical diagnosis, using routine methods, will be analyzed. The differences of thermographic imaging between an inflamed organ of a subject to a non inflamed same organ of a normal control will also be analyzed. The management of the patient will be by standard practice and will not be influenced by the thermographic camera image and the study outcome.

Study Overview

Status

Unknown

Conditions

Detailed Description

Patients aged between 5 years and 18 years, who attend the primary health clinic for medical treatment with a complaint of only sore throat and fever will be offered to participate in the study and have a thermal camera photo of the tonsils. The study group will consist of 100 patients. Fifty patients will be enrolled who present with sore throat and another 50 patients will be enrolled who present to the clinic for any febrile condition other than a sore throat. A parent will sign consent after the parent and child have received an explanation about the study. The patient will be photographed twice by directing the camera externally to each tonsil from below the mandibular angle. The photograph will be saved in the camera and the investigator will not be able to see the photo. The number of the photograph will be listed with the patient name. The investigator will keep the list and only he will have access to the clinical data. Thereafter a standard clinical examination will be performed and all the patients will receive standard medical treatment irrespective of their participation in the study. The description of the tonsils and the pharynx will be recorded in the patient's electronic medical file and will consist of the following information (one or more of the following options): normal tonsils and pharynx, redness of tonsils and/or pharynx, exudates on tonsils, petechiae of the palate. Patients who will not have the full description as described above will be excluded from analysis from the study. The data will be analyzed descriptively for a correlation between the clinical findings and the thermal photograph

Study Type

Interventional

Enrollment (Anticipated)

100

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

      • Tel Aviv, Israel
        • Primary Care Clinic of Clalit Health Services

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

5 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients aged between 5 years and 18 years who attend the primary health clinic for medical treatment with a complaint of sore throat and fever
  2. The control group will consist of patients with fever aged between 5 years and 18 years who attend the primary health clinic for medical treatment complaint other than sore throat

Exclusion Criteria:

1. Patients who are already treated with antibiotics

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: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Thermal camera by Flir HM series
all patients in both study and control groups will undergo thermal camera photo of the tonsils by Flir HM series
The patient will be photographed twice by directing the camera externally to each tonsil from below the mandibular angle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Correlation between the symptoms of sore throat and fever and the temperature of the tonsils as measured by the thermal photograph.
Time Frame: one day
one day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between clinical diagnosis of tonsillitis and thermal camera photo
Time Frame: one day
Correlation between tonsillitis characterized by redness of tonsils and/or pharynx, exudates on tonsils, petechiae of the palate and temperature of the tonsils as measured by the thermal camera photo.
one day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Doron Carmi, MD, Clalit health services

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

September 1, 2016

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 1, 2018

Study Registration Dates

First Submitted

January 1, 2013

First Submitted That Met QC Criteria

January 31, 2013

First Posted (Estimate)

February 1, 2013

Study Record Updates

Last Update Posted (Estimate)

January 27, 2016

Last Update Submitted That Met QC Criteria

January 26, 2016

Last Verified

January 1, 2016

More Information

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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