A Prospective Blinded Study to Evaluate and Characterise an Assay for the Diagnosis of Breast Cancer Using Synchrotron-Derived X-Ray Diffraction of Hair Fibres.
The test has the potential to improve the diagnostic (and consequently therapeutic) paradigm
for breast cancer.
Women attending a radiology clinic in the Mater Hospital, Sydney, for a mammogram will be
invited to participate in the study. A few hairs will be cut from their head or pubic
region, put into a coded container and sent to the sponsor for analysis by synchrotron-x-ray
diffraction. Although an imperfect standard for a variety of reasons, mammography is the
standard screening assay, and confirmation of the pathology of the lesions found by
mammography is carried out by biopsy. This will be the standard to which the hair test
results will be compared. A negative mammogram will confirm a negative hair test, but a
negative mammogram combined with a positive hair diffraction test will need a different
approach. In the event of a positive hair test and a negative second read of the mammogram,
the patient will be contacted by the referring practitioner. Patients in this category will
be offered a breast MRI. A negative breast MRI under these circumstances will be classified
as a true negative.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Diagnostic
The primary outcome is the determination of the accuracy (sensitivity and specificity) of the x-ray diffraction test for breast cancer using hair. Sensitivity is defined as the proportion of all positive Fermiscan tests that are true positives.
Phillip Yuile, MBBS (Hons), FRNZCR
The Mater Hospital, Sydney
Australia: National Health and Medical Research Council