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Use of Hair to Diagnose the Presence of Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00419900
Recruitment Status : Unknown
Verified January 2007 by Fermiscan Ltd.
Recruitment status was:  Recruiting
First Posted : January 9, 2007
Last Update Posted : January 9, 2007
Information provided by:
Fermiscan Ltd

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Procedure: diagnosis of breast cancer by x-ray diffraction of hair Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single
Primary Purpose: Screening
Study Start Date : December 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Accuracy (sensitivity and specificity) of the breast cancer test based on detection of an abnormal pattern of hair x-ray diffraction compared to the gold standard of mammography plus biopsy where indicated

Secondary Outcome Measures :
  1. The prevalence of a positive hair x-ray diffraction pattern and a negative mammogram; and the prevalence of a negative hair x-ray diffraction pattern and a positive mammogram;

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00419900

Contact: Peter W French, BSc, MSc, PhD +61292454460 pfrench@fermiscan.com.au
Contact: Gary Corino, BSc +61292454460 gcorino@fermiscan.com.au

Australia, New South Wales
Bankstown Diagnostic Imaging Centre Recruiting
Sydney, New South Wales, Australia, 2200
Campbelltown Ultrascan Radiology Recruiting
Sydney, New South Wales, Australia
Diagnostic Imaging Centre, St George Private Hospital Recruiting
Sydney, New South Wales, Australia
Liverpool Ultrascan Radiology Recruiting
Sydney, New South Wales, Australia
Penrith Imaging Recruiting
Sydney, New South Wales, Australia
Sponsors and Collaborators
Fermiscan Ltd
Principal Investigator: Phillip Yuile, MBBS, FRACR Radiation Oncology Associates, Sydney, Australia