Breast Cancer Clinical Trial
Official title:
A Pilot Research Study: Breast Cancer Combined Visualization And Characterization Tools - Novel Positron Emission Mammography System and Liquid Biopsy
The goal of this pilot research study is to compare two experimental tests, namely Liquid Biopsy and Positron Emission Mammography (PEM) in women at high risk of breast cancer. The plan for this study is to evaluate if findings from Liquid Biopsy can be matched to images obtained by PEM. Liquid Biopsy is a blood test that can detect early tumours in patients with malignancies, while PEM is an imaging tool equipped with a high-resolution camera that uses an injected positron emitting isotope to locate breast tumours. Participation in this study entails a blood draw for Liquid Biopsy test and a PEM imaging exam before undergoing a magnetic resonance imaging (MRI) - guided biopsy for a suspicious breast lesion. If correlations between paired samples are observed between imaging using PEM and the Liquid Biopsy data, further studies will be conducted to evaluate if these techniques can help refine screening investigations and ultimately reduce the unnecessary biopsies and anxiety in high-risk populations.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | September 21, 2024 |
Est. primary completion date | September 21, 2024 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Individuals who are older than 18 years of age - Individuals who are planned to undergo an MRI-guided biopsy based on high- risk screening imaging detected lesions - Individuals with the ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: - High-risk Individuals with screening-imaging studies without suspicious lesions detected by the standard of care mammogram and/or MRI - Individuals who are pregnant or who think they may be pregnant - Individuals who are breast-feeding |
Country | Name | City | State |
---|---|---|---|
Canada | University Health Network | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
University Health Network, Toronto |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Correlation of paired samples between Liquid Biopsy data and Positron Emission Mammography (PEM) images | Once PEM and Liquid Biopsy data are obtained, their correlation in paired samples will be evaluated for any novel findings on tumour fragment size and patterns, mutational signatures, variants, or epigenetic changes identified from the Liquid Biopsy that correlate in paired samples with characteristics of the PEM images. | 1 year |
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