Breast Cancer
Conditions
Keywords
Positron Emission Mammography (PEM), Liquid Biopsy
Brief summary
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.
Interventions
GENETICLiquid Biopsy
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.
PEM produces high-sensitivity images of breasts with low levels of F-18 FDG.
Sponsors
University Health Network, Toronto
Radialis Inc.
The Princess Margaret Cancer Foundation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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 * Individuals with known allergies to F-18 FDG
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluating the performance of PEM and Liquid Biopsy in visualizing and characterizing breast abnormalities | 3 years | 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. |
Countries
Canada
Contacts
CONTACTSamira Taeb, MSc
CONTACTVivianne Freitas, MD
PRINCIPAL_INVESTIGATORVivianne Freitas, MD
University Health Network, Toronto
Outcome results
None listed