Characterization of a Test for Invasive Breast Cancer Using X-ray Diffraction of Hair—Results of a Clinical Trial

Journal Article · 10 November 2009 · Breast Cancer: Basic and Clinical Research

DOI: https://doi.org/10.4137/bcbcr.s3596 · OSTI ID:1629827

Corino, Gary L. ^[1]; French, Peter W. ^[2]; Lee, Myungae ^[3]; Ajaj, Mariam M. ^[2]; Haklani, Joseph ^[2]; Mistry, Dharmica A. H. ^[2]; Phan, Kevin ^[2]; Yuile, Phillip G. ^[4]

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1. Fermiscan Pty Ltd, Sydney, NSW (Australia); DOE/OSTI
2. Fermiscan Pty Ltd, Sydney, NSW (Australia)
3. Univ. of Chicago, IL (United States). Consortium for Advanced Radiation Sources
4. Radiation Oncology Associates, Mater Hospital, Sydney, NSW (Australia)

Objective: To assess the performance of a test for breast cancer utilizing synchrotron x-ray diffraction analysis of scalp hair from women undergoing diagnostic radiology assessment. Design and Setting: A double-blinded clinical trial of women who attended diagnostic radiology clinics in Australia. Patients: 1796 women referred for diagnostic radiology, with no previous history of cancer. Main Outcome Measures: Sensitivity, specificity and accuracy of the hair test analysis compared to the gold standard of imaging followed by biopsy where indicated. Results: The hair-based assay had an overall accuracy of > 77% and a negative predictive value of 99%. For all women, the sensitivity of both mammography and X-ray diffraction alone was 64%, but when used together the sensitivity rose to 86%. The sensitivity of the hair test for women under the age of 70 was 74%. Conclusion: In this large population trial the association between the presence of breast cancer and an altered hair fiber X-ray diffraction pattern previously reported has been confirmed. It appears that mammography and X-ray diffraction of hair detect different populations of breast cancers, and are synergistic when used together.

• Research Organization: Lawrence Berkeley National Laboratory (LBNL), Berkeley, CA (United States)
• Sponsoring Organization: USDOE Office of Science (SC), Basic Energy Sciences (BES)
• Grant/Contract Number: AC02-06CH11357
• OSTI ID: 1629827
• Journal Information: Breast Cancer: Basic and Clinical Research, Journal Name: Breast Cancer: Basic and Clinical Research Vol. 3; ISSN 1178-2234
• Publisher: SAGECopyright Statement
• Country of Publication: United States
• Language: English