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Dynamic Infrared Thermography in Breast Cancer Diagnostics

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02829021
Enrollment
168
Registered
2016-07-12
Start date
2009-04-30
Completion date
2012-06-30
Last updated
2016-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Sensitivity, Specificity, Breast cancer, Mammography, Thermography, Infrared, Dynamic, Diagnostic accuracy, Diagnostic odds ratio

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).

Interventions

DEVICEFLIR ThermaCAM P-65

Women recalled for assessment after positive screening mammography were offered dynamic infrared thermography before clinical mammography and further tests.

Sponsors

University Hospital of North Norway
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
50 Years to 69 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic accuracy of Thermography compared with Mammography and breast biopsy.BaselineCan 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.

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026