Dynamic Infrared Thermography in Breast Cancer Diagnostics

Study Overview
=================
Brief Summary
-----------------
This study evaluate diagnostic accuracy of dynamic infrared thermography compared to mammography (reference test) in breast cancer diagnostics. Women aged 50-70 years, selected for assessment after mammography screening were invited to dynamic infrared thermography before clinical mammography and further examination.

Detailed Description
-----------------
This study evaluate diagnostic accuracy of dynamic infrared thermography compared to mammography (reference test) in breast cancer diagnostics. Dynamic infrared thermography (DIRT) is an imagine procedure offering a non-invasive, painless examination without risk of radiation. Dynamic infrared thermography does not provide information on the morphological characteristics of the breast, rather it provides functional information on thermal and vascular conditions of the tissue (Fitzgerald, 2012). During the study period from April 2009 until June 2012, a total of 168 women aged 50-70 years who were recalled for assessment after positive mammography screening were offered dynamic infrared thermography before further tests (clinical mammography, clinical examination and if necessary breast tissue biopsy). Radiographers at the Breast Diagnostic Center (BDS) at University Hospital North Norway collected information about parity, menopausal status, use of hormone therapy and size of bra. The same radiographers also carried out all the dynamic infrared thermography examinations. PI Åshild O. Miland and Professor James B. Mercer interpreted the thermograms and entered the data into the thermography database. Both were blinded for further assessments (mammography, clinical examination and biopsy) and non of them talked to any of the participants after the examination. The health professionals who were responsible for the women during mammography, clinical examination and biopsy were blinded for the results from the infrared digital thermography examination. They were not allowed to ask the women about the infrared digital thermography examination. The three radiologists at BDS made the interpretation of the mammographies and entered data into the digital patient journal and to the mammography database at The Norwegian Cancer Registry. One of the radiologist took, when necessary, breast biopsies. A breast surgeons were responsible for the clinical breast examination. Pathologists verified the histology. Breast radiologist Jan Ole Frantzen and researcher Merethe Kumle, MD, PhD collected information about breast cancer results from the digital patient journal and Roentgen information system (RIS) and entered it into a separate mammography database. The thermography database and the mammography database was still not merged at the time of registration in ClinicalTrials.gov (March 2015).

Official Title
-----------------
Dynamic Infrared Thermography in Breast Cancer Diagnostics. A Diagnostic Accuracy Study Comparing Dynamic Infrared Thermography Against Mammography (Reference Standard)

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Device: FLIR ThermaCAM P-65


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women, aged 50-69 attending the Norwegian Breast Screening Program, recalled for assessment after positive mammography screening Exclusion Criteria: not attending the Norwegian Breast Screening Program, recalled to mammography for other reason than positive screening mammogram.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 69 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Thermography and mammography<br>All participants will be examined with Dynamic infrared thermography (FLIR ThermaCAM P-65) Mammography, clinical examination and if necessary breast tissue biopsy to diagnose breast cancer. | Device: FLIR ThermaCAM P-65<br>* Women recalled for assessment after positive screening mammography were offered dynamic infrared thermography before clinical mammography and further tests.<br>* Other names: Serial number: 25300659;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of Thermography compared with Mammography and breast biopsy. | Can thermography distinguish benign from malign tumours in breast cancer diagnostics. The gold standard is breast biopsy pathology. The outcome is measured as number of subjects with pathological diagnosis of cancer. | Baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sensitivity, Specificity, Breast cancer, Mammography, Thermography, Infrared, Dynamic, Diagnostic accuracy, Diagnostic odds ratio