NCT02829021

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Apr 2009

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

April 12, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 12, 2016

Completed
Last Updated

July 12, 2016

Status Verified

June 1, 2016

Enrollment Period

3.2 years

First QC Date

April 12, 2016

Last Update Submit

July 7, 2016

Conditions

Breast Cancer

Keywords

SensitivitySpecificityBreast cancerMammographyThermographyInfraredDynamicDiagnostic accuracyDiagnostic odds ratio

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Thermography and mammography

OTHER

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

Interventions

FLIR ThermaCAM P-65DEVICE

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

Also known as: Serial number: 25300659
Thermography and mammography

Eligibility Criteria

Age50 Years - 69 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women,
  • aged 50-69
  • attending the Norwegian Breast Screening Program,
  • recalled for assessment after positive mammography screening

You may not qualify if:

  • not attending the Norwegian Breast Screening Program,
  • recalled to mammography for other reason than positive screening mammogram.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Åshild Odden Miland

Tromsø, Tromsø, 9037, Norway

Location

MeSH Terms

Conditions

Breast NeoplasmsHypersensitivity

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesImmune System Diseases

Study Officials

  • Åshild O. Miland, PhD

    Senior lecturer

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2016

First Posted

July 12, 2016

Study Start

April 1, 2009

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

July 12, 2016

Record last verified: 2016-06

Locations

NO(1)