Dynamic Infrared Thermography in Breast Cancer Diagnostics
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

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).
    

Intervention name(s): FLIR ThermaCAM P-65
Intervention type(s): Device
Intervention description(s): Women recalled for assessment after positive screening mammography were offered dynamic infrared thermography before clinical mammography and further tests.
Other intervention name(s): Serial number: 25300659
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Sensitivity; Specificity; Breast cancer; Mammography; Thermography; Infrared; Dynamic; Diagnostic accuracy; Diagnostic odds ratio