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Trial Title:
Use of Hair to Diagnose the Presence of Breast Cancer
NCT ID:
NCT00419900
Condition:
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
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Screening
Masking:
Single
Intervention:
Intervention type:
Procedure
Intervention name:
diagnosis of breast cancer by x-ray diffraction of hair
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:
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.
Gender:
Female
Minimum age:
20 Years
Maximum age:
N/A
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Bankstown Diagnostic Imaging Centre
Address:
City:
Sydney
Zip:
2200
Country:
Australia
Status:
Recruiting
Facility:
Name:
Campbelltown Ultrascan Radiology
Address:
City:
Sydney
Country:
Australia
Status:
Recruiting
Facility:
Name:
Diagnostic Imaging Centre, St George Private Hospital
Address:
City:
Sydney
Country:
Australia
Status:
Recruiting
Facility:
Name:
Liverpool Ultrascan Radiology
Address:
City:
Sydney
Country:
Australia
Status:
Recruiting
Facility:
Name:
Penrith Imaging
Address:
City:
Sydney
Country:
Australia
Status:
Recruiting
Start date:
December 2006
Lead sponsor:
Agency:
Fermiscan Ltd
Agency class:
Industry
Source:
Fermiscan Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT00419900