Dynamic Infrared Thermography in Breast Cancer Diagnostics

July 7, 2016 updated by: University Hospital of North Norway

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

168

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

  • Norway
      • Tromsø, Norway, 9037
        • Åshild Odden Miland

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

50 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Thermography and mammography

All participants will be examined with

  1. Dynamic infrared thermography (FLIR ThermaCAM P-65)
  2. Mammography, clinical examination and if necessary breast tissue biopsy to diagnose breast cancer.
Device: FLIR ThermaCAM P-65
Women recalled for assessment after positive screening mammography were offered dynamic infrared thermography before clinical mammography and further tests.
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.
Time Frame: Baseline

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

Collaborators and Investigators

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

Sponsor

University Hospital of North Norway

Investigators

  • Principal Investigator: Åshild O. Miland, PhD, Senior Lecturer

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

April 1, 2009

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

April 12, 2016

First Submitted That Met QC Criteria

July 7, 2016

First Posted (Estimate)

July 12, 2016

Study Record Updates

Last Update Posted (Estimate)

July 12, 2016

Last Update Submitted That Met QC Criteria

July 7, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REK-109/2008
  • FAST-67 (Registry Identifier: University hospital of North Norway)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

This is a small Diagnostic Accuracy Study, the investigators will decide upon data sharing when they have finished the statistical analysis. If someone is interested in the data, please contact the investigators.

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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