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| Name | Class |
|---|---|
| Radialis Inc. | INDUSTRY |
| The Princess Margaret Cancer Foundation | OTHER |
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The goal of this research study is to evaluate the performance of 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 assess whether findings from the combination or each individual test can assist radiologists in visualizing and characterizing beast abnormalities.
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 a low dose of 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 PEM and/or Liquid Biopsy provide accurate information to assist radiologists in visualizing and characterizing breast abnormalities, this method may serve as the first step towards establishing these genomic and new imaging technologies as new diagnostic modalities and ultimately reduce the unnecessary biopsies and anxiety in high-risk populations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liquid Biopsy and Positron Emission Mammography (PEM) | Experimental | To perform the Liquid Biopsy assays, a baseline blood sample will be collected prior to the MRI-guided biopsy, and a follow-up blood and a tissue sample (if available) may be requested post-surgery If malignancy is confirmed by the standard of care histopathology results. To perform the Positron Emission Mammography (PEM), participants will be injected with 74 megabecquerel (MBq) of commercially distributed 2-[fluorine-18]-fluoro-2-deoxy-D-glucose (F-18 FDG). Following a delay of one hour for F-18 FDG uptake, the study participants will undergo a bilateral 4-view combination PEM scan. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liquid Biopsy | Genetic | Detects cell-free DNA (cfDNA) circulating in the blood by whole-genome sequencing (WGS). It also detects cfDNA containing epigenetic marks by cell-free methylated DNA immunoprecipitation and high throughput sequencing assays and may determine the concordance of genomic alterations between tumour tissue (if available) and matched plasma samples by WGS. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluating the performance of PEM and Liquid Biopsy in visualizing and characterizing breast abnormalities | The performance of PEM and/or Liquid Biopsy, including percent sensitivity, specificity, positive and negative predictive values, in visualization and characterization of suspicious breast abnormalities will be evaluated and compared to magnetic resonance imaging (MRI), and digital mammography. | 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Samira Taeb, MSc | Contact | 416-946-4501 | 5853 | samira.taeb2@uhn.ca |
| Vivianne Freitas, MD | Contact | 416-946-2000 | 5608 | vivianne.freitas@uhn.ca |
| Name | Affiliation | Role |
|---|---|---|
| Vivianne Freitas, MD | University Health Network, Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Health Network | Recruiting | Toronto | Ontario | M5G 2M9 | Canada |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000073890 | Liquid Biopsy |
| ID | Term |
|---|---|
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
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| Positron Emission Mammography (PEM) | Device | PEM produces high-sensitivity images of breasts with low levels of F-18 FDG. |
|
| D017437 |
| Skin and Connective Tissue Diseases |
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D008919 | Investigative Techniques |