Positron Emission Mammography and Liquid Biopsy in Women With High-risk Breast Screenings

University Health Network, Toronto100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

100

Conditions

Breast Cancer

Interventions

Liquid BiopsyGENETIC

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 3 years