Use of Hair to Diagnose the Presence of Breast Cancer
Conditions
Breast Cancer
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
breast cancer, diagnosis, x-ray diffraction, synchrotron, hair
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Screening
Intervention
Name: diagnosis of breast cancer by x-ray diffraction of hair
Type: Procedure
Overall Status
Recruiting
Summary
Using synchrotron X-ray diffraction, it has been reported that a hair from an individual with breast cancer exhibits a difference in its molecular structure compared to that of an individual without breast cancer. This difference is visible in the X-ray diffraction pattern as a ring superimposed on the pattern for normal hair.

The hypothesis of this study is that synchrotron x-ray diffraction can be used to differentiate hairs from women with medically diagnosed breast cancer from women not known to have the disease.

To test this hypothesis, hair from 2000 women attending radiology clinics for mammography will be collected, analysed by x-ray diffraction and then analysed using Fermiscan proprietary image analysis software. The mammogram status of the subjects will be blinded from the diffraction analysts. Results will then be compared with mammography results to allow a direct comparison between the Fermiscan test and mammography in terms of specificity and sensitivity.
Criteria for eligibility
Healthy Volunteers: Accepts Healthy Volunteers
Maximum Age: N/A
Minimum Age: 20 Years
Gender: Female
Criteria: Inclusion Criteria:

- Adult women (aged >20) who are undergoing mammography, and

- Who are willing and able to provide informed consent; and

- Who have usable scalp and/or pubic hair

Exclusion Criteria:

- Women who have dyed or permed their scalp hair within the previous 6 weeks and whose pubic hair is unavailable;

- Women with a history of breast cancer ever or other cancers (excluding non-melanoma skin cancer and CIN [cervical intra-epithelial neoplasia]) within 5 years.
Locations
Bankstown Diagnostic Imaging Centre
Sydney, New South Wales, Australia
Status: Recruiting
Campbelltown Ultrascan Radiology
Sydney, New South Wales, Australia
Status: Recruiting
Diagnostic Imaging Centre, St George Private Hospital
Sydney, New South Wales, Australia
Status: Recruiting
Liverpool Ultrascan Radiology
Sydney, New South Wales, Australia
Status: Recruiting
Penrith Imaging
Sydney, New South Wales, Australia
Status: Recruiting
Start Date
December 2006
Sponsors
Fermiscan Ltd
Source
Fermiscan Ltd
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page